Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) (COGENT-1)

January 27, 2009 updated by: Cogentus Pharmaceuticals

A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Harbour Cardiology
      • Eastwood, New South Wales, Australia, 2122
        • Cardiac Research Institute
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Wesley Research Institute
      • Cairns, Queensland, Australia, 4870
        • Cairns Base Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Epping, Victoria, Australia, 3076
        • Northern Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St.Vincent's Hospital (Melb)
      • Geelong, Victoria, Australia, 3220
        • Geelong Hospital- Barwon Health
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Dimitrovgrad, Bulgaria
        • Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases
      • Pleven, Bulgaria
        • Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology
      • Plovdiv, Bulgaria
        • Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic
      • Plovdiv, Bulgaria
        • Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit
      • Rousse, Bulgaria
        • Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases
      • Sofia, Bulgaria
        • 4th Multiprofile Hospital for Active Treatment
      • Sofia, Bulgaria
        • Military Medical Academy, Clinic of Cardiology and Intensive Care
      • Sofia, Bulgaria
        • Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic
      • Sofia, Bulgaria
        • National Heart Hospital Department of Cardiology
      • Sofia, Bulgaria
        • National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic
      • Sofia, Bulgaria
        • Tokuda Hospital Department of Cardiology
      • Sofia, Bulgaria
        • University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic
      • Varna, Bulgaria
        • Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department
      • Quebec, Canada, G1R2J6
        • Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec
      • Quebec, Canada, G1V4G5
        • Laval Hospital
    • British Columbia
      • Maple Ridge, British Columbia, Canada, V2X 5Z6
        • Dr. Tsui
      • New Westminster, British Columbia, Canada, V3L3W4
        • Fraser Clinical Trials Inc and Royal Columbian Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Victoria, British Columbia, Canada, V8R4R2
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Health Sciences Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C4B7
        • South East Regional Health Authority
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N1W7
        • Commonwealth Medical Clinic
    • Ontario
      • Cambridge, Ontario, Canada, NIR-6V6
        • Cambridge Cardiac Care Centre
      • Mississauga, Ontario, Canada, L5B2P7
        • Mississauga Clinical Research Center
      • Niagara Falls, Ontario, Canada, L2G5X7
        • Dr. George Zimakas
      • Oshawa, Ontario, Canada, L1J2K1
        • Dr. James Y. Cha
      • Thunder Bay, Ontario, Canada, P7R2Z3
        • Curans Health Center
      • Toronto, Ontario, Canada, M4C-1N2
        • Toronto East Cardiology Associates Inc.
    • Quebec
      • Granby, Quebec, Canada, J2G8Z9
        • Recherches Cliniques Theradev
      • Greenfield Park, Quebec, Canada, J4N1L6
        • Viacar Recherche Clinique Inc.
      • Longueuil, Quebec, Canada, J4N1L6
        • ViaCar Recherche Clinique Inc
      • Montreal, Quebec, Canada, H2W 1T8
        • Hospitalier de l'Universite de Montreal Hotel Dieu
      • Montreal, Quebec, Canada, H4J1C5
        • Sacré-Cœur Hospital
      • St. Charles-Borromee, Quebec, Canada, J6E6J2
        • Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL
      • St. George, Quebec, Canada, G5Y5B7
        • Centre Hospitalier Beauce-Etchemin
      • Trois Rivieres, Quebec, Canada, G8Z 3R9
        • Clinique de Cardiologie de Trois-Rivieres
      • Westmount, Quebec, Canada, H3Z2M6
        • Cardiology and Research
      • Antofagasta, Chile
        • Clinica Antofagasta
      • Osorno, Chile
        • Corporacion de Beneficencia Osorno
      • Punta Arenas, Chile
        • Hospital Regional de Punta Arenas Dr. Lautaro Navarro
      • Santiago, Chile
        • Instituto Nacional del Tórax
      • Santiago, Chile
        • Hospital del Salvador
      • Santiago, Chile, 8207257
        • Complejo Asistencial Dr.Sótero del Río
      • Temuco, Chile
        • Centro de Estudios Cardiovascular
      • Viña del Mar, Chile
        • Hospital Dr. Gustavo Fricke
      • Viña del Mar, Chile
        • Clínica Reñaca
      • Viña del Mar, Chile
        • Hospital Naval Almirante Neff
      • Frydek-Mistek, Czech Republic, 738 18
        • Nemocnice ve Frydku-Mistku
      • Hradec Kralove, Czech Republic, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Liberec, Czech Republic, 460 63
        • Krajska nemocnice Liberec, a. s.
      • Litomysl, Czech Republic, 570 14
        • Litomyslska nemocnice a. s.
      • Ostrava, Czech Republic, 702 00
        • Kardiologicka ambulance
      • Ostrava Vítkovice, Czech Republic, 703 00
        • Kardiologicka a Angiologicka Ambulance
      • Pardubice, Czech Republic, 532 03
        • Pardubicka krajska nemocnice, a.s.
      • Praha 2, Czech Republic, 12808
        • II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze
      • Praha 4, Czech Republic, 140 21
        • Klinika kardiologie Institut klinické a experimentální medicíny
      • Zlín, Czech Republic, 762 75
        • Krajska nemocnice T. Bati a.s.
      • Znojmo, Czech Republic, 669 02
        • Nemocnice Znojmo, p.o.
      • Albi, France, 81000
        • Centre hospitalier d'Albi
      • Dijon Cedex, France, 21079
        • Centre de Cardiologie CHRU Dijon
      • Essey les Nancy Cedex, France, 54270
        • Clinique Pasteur
      • Lille Cedex, France, 59037
        • CHRU de Lille Hôpital Cardiologique
      • Marseille, France, 13385
        • Hôpital La Timone-Adultes
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris Cedex 13, France, 75651
        • La Pitié Salpétrière Institut de Cardiologie
      • St Jean de Verges, France, 09000
        • Centre Hospitalier Intercommunal du Val d'Ariège
      • Toulouse Cedex 4, France, 31403
        • Centre Hospitalier Rangueil Larrey
      • Berlin, Germany, 10117
        • Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie
      • Berlin, Germany, 12351
        • Vivantes Clinic Neuköln Berlin
      • Berlin, Germany, 13509
        • Vivantes Humbolt Klinikum
      • Biberach, Germany, 88400
        • Praxis Dr. med. Boscher
      • Bochum, Germany, 44791
        • St. Josef-Hospital Medizinische Klinik II, Kardiologie
      • Bonn, Germany, 53115
        • St.-Marien-Hospital Bonn
      • Bonn-Lengsdorf, Germany, 53127
        • Dr. THomas Klingenheben
      • Brandenburg, Germany, 14770
        • Stadtisches Klinikum Brandenburg GmbH
      • Chemnitz, Germany, 09113
        • MVZ am Küchwald GmbH
      • Dinslaken, Germany, 46535
        • Gemeinschaftspraxis Innere Medizin und Kardiologie
      • Dortmund, Germany, 44137
        • St.-Johannes-Hospital Dortmund
      • Dresden, Germany, 1099
        • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
      • Erfurt, Germany, 990804
        • Practice of Cardiology
      • Essen, Germany, 45138
        • Elisabeth.Krankenhaus
      • Hamburg, Germany, 22291
        • Asklepios Klinik Barmbek
      • Hamburg, Germany, 20099
        • Asklepios Klinik St.Georg
      • Hamburg, Germany, 22527
        • Universitäres Herz-und Gefäßzentrum Hamburg"
      • Hamburg, Germany, 22765
        • Kardiologische Praxis Hamburg Altona
      • Hannover, Germany, 30167
        • Klinikum Region Hannover Krankenhaus Nordstadt
      • Hartmannsdorf, Germany, 09232
        • Kardiologische Gemeinschaftspraxis
      • Karlsbad, Germany, 76307
        • SRH Klinikum Karlsbad-Langensteinbach
      • Koln, Germany, 53109
        • Kliniken der Stadt Köln, Köln Merheim
      • Lahr, Germany, 77933
        • Herzzentrum Lahr
      • Leipzig, Germany, 04289
        • Universität Leipzig - Herzzentrum
      • Leipzig, Germany, 04103
        • Kardiologische Gemeinschaftpraxis
      • Ludwigshafen, Germany, 67067
        • Praxis für Innere Medizin, Gastroenterologie
      • Lübeck, Germany, 23538
        • Universitätsklinikum Lübeck
      • Lüneburg, Germany, 21339
        • Gemeinschaftspraxis
      • Mainz, Germany, 55131
        • Klinikum der Johannes-Gutenberg-Universitat
      • Mannheim, Germany, 68165
        • Gemeinschaftspraxis
      • Mannheim, Germany, 68167
        • Klinikum Mannheim GmbH, Universaitatskinikum
      • Markkleeberg, Germany, 04416
        • Kardiologische Praxis
      • Melsungen, Germany, 34212
        • Asklepios Klinik Melsungen
      • Mönchengladbach, Germany, 41063
        • Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus
      • Mühldorf a.d. Inn, Germany, 84453
        • Internist/Kardiologe/Angiologe
      • Nienburg, Germany, 31582
        • Kardiologische Gemeinschaftspraxis
      • Pirna, Germany, 01796
        • Klinikum Pirna GmbH
      • Regensburg, Germany, 93053
        • Universitätsklinik Regensburg
      • Reinbek, Germany, 21465
        • Krankenhaus Reinbek St. Adolf-Stift
      • Riesa, Germany, 01589
        • Kardiologische Gemeinschaftspraxis
      • Rottweil, Germany, 78628
        • Internistische Praxis
      • Siegen, Germany, 57072
        • Zentrum für Prävention und Rehabilation
      • Soest, Germany, 59494
        • Marienkrankenhaus Soest
      • Stuhr, Germany, 28816
        • Praxisgemeinschaft Stuhr-Brinkum
      • Tubingen, Germany, 72076
        • Medizinische Universitätsklinik
      • Warendorf, Germany, 48231
        • Josephs-Hospital Warendorf
      • Wermsdorf, Germany, 04779
        • Kardiologische Praxis
      • Weyhe-Leeste, Germany, 28844
        • Dr. Andreas Schreckenberg
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr
      • Wuppertal, Germany, 42117
        • Helios Klinikum Wuppertal
      • Baja, Hungary, H-6500
        • Bajai Kórház
      • Budapest, Hungary, H-1027
        • Budai Irgalmasrendi Korhaz
      • Budapest, Hungary, H-1041
        • Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet
      • Budapest, Hungary, H-1096
        • Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
      • Kalocsa, Hungary, H-6300
        • Városi Önkormányzat Kórház-Rendelőintézet
      • Nyíregyháza, Hungary, H-4400
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Toszegi, Hungary, H-5004
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
      • Vác, Hungary, H-2600
        • Javorszky Odon Korhaz
      • Zalaegerszeg, Hungary, H-8900
        • Zala Megyei Kórház
      • Bergamo, Italy, 24128
        • Ospedali Riuniti di Bergamo
      • Codogno (Lodi), Italy, 26845
        • Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche
      • Mantova, Italy, 46100
        • Azienda Ospeedaliera Carlo Poma
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita' Di Novara
      • Rozzano (Milano), Italy, 20089
        • Istituto Clinico Humanitas
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiologica Aguascalientes
      • D. F., Mexico, cp 06090
        • Hospital de Jesús
      • Durango, Mexico, C. P 34080
        • Cardioprevent
      • Puebla, Mexico, 72190'
        • Hospital Angeles de Puebla
      • Puebla, Mexico, 72490
        • Hospital General de Puebla
      • Queretaro, Mexico, 76178
        • Instituto de Corazón de Querétaro, S.A. de C.V.
      • San Luis Potosi, Mexico, 78240
        • Hospital Central "Dr. Ignacio Morones Prieto"
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Hospital "Valentín Gómez Farías"
    • San Lusi Potosi
      • San Luis Potosi, San Lusi Potosi, Mexico, 78200
        • Cardioarritmias e Investigación, S.C.
      • Bydgoszcz, Poland, 85-168
        • Oddział Kardiologii z Zakładem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,
      • Bydgoszcz, Poland, 85-435
        • NZOZ "Medicus" Jacek Kubica
      • Bydgoszcz, Poland, 85-826
        • Wojewódzki Szpital Meijski im. Biziela, Oddział Kardiologii - SPZOZ
      • Dębica, Poland, 39-200
        • Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy
      • Gdańsk, Poland, 80-437
        • Zakład Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o
      • Gdynia, Poland, 81-472
        • Gabinet Kardiologiczno-Internistyczny
      • Gdynia, Poland, 81-423
        • Gabinet Kardiologiczny Medipuls
      • Gdynia, Poland, 81-572
        • Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo
      • Gliwice, Poland, 44-100
        • NZOZ Medicus, Poradnia Kardiologiczna
      • Gliwice, Poland, 44-100
        • Oddział Kardiologii i INK, SPZOZ nr 1
      • Grodzisk Mazowiecki, Poland, 05-825
        • Mazowieckie Centrum Badań Klinicznych Iwona Czajkowska, Monika Śmietańska s.c.
      • Inowroclaw, Poland, 88-100
        • Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny
      • Katowice, Poland, 40-752
        • Oddział Chorób Wewnętrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
      • Kościerzyna, Poland, 83-400
        • Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii
      • Krakow, Poland, 31-121
        • Oddział Kardiologii, Szpital Specjalistyczny im. J. Dietla
      • Krakow, Poland, 31-202
        • "Klinika Choroby Wieńcowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagielloński
      • Kraków, Poland, 31-913
        • Oddzial Chorób Wewnętrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie
      • Kutno, Poland, 99-300
        • Niepubliczny Zakład Opieki Zdrowotnej Specjalista Sp. z o.o.
      • Limanowa, Poland, 34-600
        • Poradnia Kardiologiczna, Oddział Chorob Wewnetrznych Szpital Powiatowy w Limanowej
      • Lubartów, Poland, 21-100
        • Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej
      • Mielec, Poland, 39-300
        • "Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego
      • Nowa Sól, Poland, 67-100
        • Oddział Kardiologii, Nowa Sól
      • Olawa, Poland, 55-200
        • ZOZ w Oławie, Oddział Chorób Wewnętrznych
      • Olsztyn, Poland, 10-045
        • "Oddział Kardiologiczno-Internistyczny
      • Opole, Poland, 45-418
        • "Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne
      • Ostrów Wielkopolski, Poland, 63-400
        • Specjalistyczny Zakład Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"
      • Pabianice, Poland, 95-200
        • II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej
      • Piotrków Trybunalski, Poland, 97-300
        • "Samodzielny Szpital Wojewódzki im. Mikołaja Kopernika, Oddział Kardiologiczny
      • Poznań, Poland, 60-218
        • Medyczne Centrum Hetmańska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczyński
      • Poznań, Poland, 60-539
        • Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór
      • Pruszków, Poland, 05-800
        • Oddział Wewnetrzny I, Szpital Kolejowy im. dr med. Włodzimierza Roeslera
      • Puławy, Poland, 24-100
        • Samodzileny Publiczny Zakład Opieki Zdrowotnej w Puławach, Szpital Specjalistyczny
      • Płock, Poland, 09-400
        • Wojewódzki Szpital Zespolony, Oddział Kardiologiczny
      • Płock, Poland, 09-402
        • Specjalistyczna Przychodnia Lekarska "Medikard"
      • Radom, Poland, 26-617
        • Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny
      • Rzeszów, Poland, 35-301
        • "Oddział Kardiologii z Pododdziałem Ostrych Zespołów Wieńcowych i z Ośrodkiem Implantacji Rozruszników Serca,
      • Sandomierz, Poland, 27-600
        • Oddział Kardiologii, SP ZZOZ Sandomierz
      • Siedlce, Poland, 08-110
        • Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach
      • Sieradz, Poland, 98-200
        • Oddział Kardiologii Samodzielny Publiczny Zakład Opieki Zdrowotnej w Sieradzu im. Kardynała Stefana Wyszyńskiego
      • Skierniewice, Poland, 96-100
        • "Oddział Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "
      • Skierniewice, Poland, 96-100
        • NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna
      • Stalowa Wola, Poland, 37-450
        • "Oddział Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki
      • Starogard Gdański, Poland, 83-200
        • Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,
      • Szczecin, Poland, 71-531
        • Indywidualna Specjalistyczna Praktyka Lekarska
      • Tarnów, Poland, 33-100
        • Poradnia Kardiologiczna
      • Tarnów, Poland, 33-100
        • Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology
      • Torun, Poland, 87 100
        • Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
      • Toruń, Poland, 87-100
        • Oddział Kardiologii Wojewódzki Szpital Zespolony
      • Warszawa, Poland, 04-749
        • Miedzyleski Szpital Specjalistyczny w Warszawie
      • Warszawa, Poland, 02-777
        • Centrum Leczenia Chorob Cywilizacyjnych
      • Warszawa, Poland, 01 - 211
        • Oddział Kardiologiczny Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej
      • Warszawa, Poland, 02-097
        • Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie
      • Warszawa, Poland, 02-637
        • II Klinika Choroby Wieńcowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego
      • Warszawa, Poland
        • NZOZ Starówka
      • Wałbrzych, Poland, 58-309
        • "Oddział Kardiologiczny Wałbrzyski Ośrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokołowskiego
      • Wroclaw, Poland, 50-981
        • Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Wrocław, Poland, 50-088
        • Synexus SCM Sp.z o o.
      • Wrocław, Poland, 50-349
        • Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych
      • Zabrze, Poland, 41-800
        • "Śląskie Centrum Chorób Serca, III Katedra i Oddział Kliniczny Kardiologii Śląskiego Uniwersytetu Medycznego
      • Łomża, Poland, 18-404
        • Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego
      • Łódź, Poland, 90-302
        • Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA
      • Łódź, Poland, 94-050
        • All-MED Centrum Medyczne
      • Ponce, Puerto Rico, 00717-1322
        • Research and Cardiovascular Corp.
      • Bacau, Romania, 600114
        • Spitalul Clinic Judetean de Urgenta Bacau
      • Bucharest, Romania, 010584
        • S.C. Duo Medical S.R.L.
      • Bucharest, Romania, 020506
        • Cardiomed SRL
      • Bucuresti, Romania, 011025
        • Centrul Medical Sana
      • Cluj-Napoca, Romania, 400001
        • Institutul Inimii "Niculae Stanicioiu"
      • Craiova, Romania, 200147
        • Cardiomed SRL
      • Iasi, Romania, 700503
        • Dr. C.I. Parhon Hospital
      • Sibiu, Romania, 550245
        • Clinical county Hospital
      • Targu Mures, Romania, 540136
        • Institutul de Boli Cardiovasculare si Transplan Tg. Mures
      • Timisoara, Romania, 300736
        • County Hospital
      • Banská Bystrica, Slovakia, 97405
        • Novamed s.r.o.
      • Bardejov, Slovakia, 085-01
        • Alian s.r.o.
      • Bratislava, Slovakia, 826 06
        • 5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov
      • Kosice, Slovakia, 040-22
        • Cardio D&R spol. s r.o.
      • Lučenec, Slovakia, 98401
        • Kardiomed s.r.o.
      • Nitra, Slovakia, 950-01
        • NZZ Kardiocentrum Nitra s.r.o.
      • Nove Zamky, Slovakia, 94052
        • MUDr. Tibor DURIS, CSc., s.r.o.
      • Považská Bystrica, Slovakia, 017 26
        • Nemocnica s poliklinikou Považská Bystrica
      • Trencin, Slovakia, 911 71
        • Fakultna nemocnica Trencin
      • Žilina, Slovakia, 010 01
        • Žilpo s.r.o.
      • Žilina, Slovakia, 010-01
        • MEDIVASA s.r.o.
      • Dnipropetrovsk, Ukraine, 49006
        • "Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2
      • Ivano-Frankivsk, Ukraine, 76005
        • Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3
      • Kyiv, Ukraine, 1032
        • TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv
      • Kyiv, Ukraine, 3680
        • Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy
      • Kyiv, Ukraine, 3680
        • Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv
      • Zaporizhzhya, Ukraine, 69000
        • Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia
      • Zhytomyr, Ukraine, 10002
        • Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Alabama Clinical Research Institute, Inc. (ACRI)
      • Birmingham, Alabama, United States, 35235
        • Birmingham Heart Clinic, PC
      • Birmingham, Alabama, United States, 35126
        • Alabama Clinical Therapeutics, LLC
      • Birmingham, Alabama, United States, 35213
        • Cardio-Thoracic Surgeons P.C.
      • Geneva, Alabama, United States, 36340
        • John F Simmons , MD PC
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants, Inc.
      • Huntsville, Alabama, United States, 35801
        • The Heart Center, PC
      • Mobile, Alabama, United States, 36608
        • Mobile Heart Specialists, PC
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Advanced Cardiac Specialists
      • Phoenix, Arizona, United States, 85029
        • Redpoint Research
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants, Ltd.
      • Sierra Vista, Arizona, United States, 85635
        • Cochise Clinical Research
      • Tucson, Arizona, United States, 85705
        • Paradigm Clinical Research, Inc.
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
        • Tri-Lakes Research
      • Hot Springs, Arkansas, United States, 71913
        • Michael A. Frais, Cardiologist, P.A.
      • Jonesboro, Arkansas, United States, 72401
        • NEA-Clinic Cardiology
      • Searcy, Arkansas, United States, 72143
        • Searcy Medical Center
    • California
      • Anaheim, California, United States, 92801
        • Cardiology Consultants Of Orange County
      • Anaheim, California, United States, 92801
        • Chest and Critical Care Consultants, A Medical Group
      • Buena park, California, United States, 90620
        • Clinical Solutions Advantage
      • Castro Valley, California, United States, 94546
        • Turns Institute for Clinical Research
      • Escondido, California, United States, 92025
        • Escondido Cardiology Associates
      • Laguna Hills, California, United States, 92653
        • Accurate Clinical Trials, Inc.
      • Laguna Hills, California, United States, 92653
        • Therapeutic Research Institute of Orange County
      • Lakewood, California, United States, 90712
        • Kirtik Thaker MD
      • Los Angeles, California, United States, 90017
        • Los Angeles Cardiology Associates
      • Merced, California, United States, 95348
        • Merced Heart Associates
      • Mission Viejo, California, United States, 92691
        • Mission Internal Medical Group
      • Mountain View, California, United States, 94040
        • Altos Cardiovascular Associates
      • Oceanside, California, United States, 92056
        • Kenneth W. Carr, MD, Cardiology
      • Rancho Cucamonga, California, United States, 91703
        • Rancho CucamongaClinical Trials
      • San Bernardino, California, United States, 92404
        • Inland Heart and Vascular Medical Associates
      • San Diego, California, United States, 92117
        • Ritchken and First
      • San Francisco, California, United States, 94117
        • Rider Research Group
      • San Francisco, California, United States, 94118
        • Richard Levy, MD.
      • San Jose, California, United States, 95119
        • Kaiser Permanente
      • Santa Ana, California, United States, 92704
        • Medical Helping Hands Research
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
      • Santa Rosa, California, United States, 95405
        • Radiant Research
      • Torrance, California, United States, 90509
        • Harbor- UCLA Medical Center
      • Ventura, California, United States, 93003
        • Ventura Cardiology Consultants Medical Group, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Health Partners
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Clinical Research
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Alfieri Cardiology, PA
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington V.A. Medical Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Oscar R. Guerra, MD PA
      • Deerfield Beach, Florida, United States, 33442
        • Deerfield Beach Cardiology Associates
      • Hallandale, Florida, United States, 33009
        • Dr Jules Cohen
      • Hialeah, Florida, United States, 33012
        • Empire International Research
      • Hollywood, Florida, United States, 33021
        • Cardiovascular Consultants of South Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32250
        • Jacksonville Heart Center
      • Jacksonville, Florida, United States, 32207
        • Jacksonville Heart Center
      • Jupiter, Florida, United States, 33458
        • CVMS Resesarch Institute, LLC
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Research
      • Melbourne, Florida, United States, 32901
        • Alpha Medical Research, Llc
      • Miami, Florida, United States, 33173
        • Cardiovascular Research Center of South Florida
      • Miami, Florida, United States, 33125
        • Empire International Research
      • Miami, Florida, United States, 33144
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33175
        • Research Center Phase I-IV of Florida Corp.
      • Miami, Florida, United States, 33186
        • Empire International Research
      • New Smyrna Beach, Florida, United States, 32168
        • Bert Fish Medical Center
      • Orlando, Florida, United States, 32803
        • Central Florida Cardiology Group
      • Orlando, Florida, United States, 32806
        • Cardiology Assocaites of Orlando d/b/a Orlando Heart Center
      • Palm Harbor, Florida, United States, 34684
        • Sunset Point Medical Associates
      • Plantation, Florida, United States, 33317
        • Berma Research Group
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart Group Research Center
      • St. Petersburg, Florida, United States, 33709
        • The Heart And Vascular Institute Of Florida
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Cardiovascular Research
      • Vero Beach, Florida, United States, 32960
        • G&G Research Baker-Tombul Cardiology
      • Weston, Florida, United States, 33326
        • Carlos Levy, D.O.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates, Inc.
      • Atlanta, Georgia, United States, 30312
        • Primary Care Specialists, LLC/ ECAST CT
      • Columbus, Georgia, United States, 31904
        • Southeast Regional Research Group
      • Covington, Georgia, United States, 30014
        • Georgia Heart Specialists, LLC
      • Decatur, Georgia, United States, 30032
        • Ialum Clinical Research Center, LLC
      • Decatur, Georgia, United States, 30032
        • Ialum Clinical Research Center
      • Decatur, Georgia, United States, 30035
        • Ialum Clinical Research Center
      • Savannah, Georgia, United States, 31406
        • Southeast Regional Research Group
      • Stockbridge, Georgia, United States, 30281
        • Medsouth Primary CareStockbridge
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • South Suburban Health Professional Group, PC
      • Melrose Park, Illinois, United States, 60160
        • Consultants in Cardiovascular Medicine
      • Peoria, Illinois, United States, 61606
        • Methodist Medical Center of Illinois
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Clinical Research Center
      • Avon, Indiana, United States, 46123
        • American Health Network
      • Elkhart, Indiana, United States, 46514
        • Indiana Medical Research
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Indianapolis, Indiana, United States, 46237
        • Indiana Heart Physicians
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
      • Waterloo, Iowa, United States, 50702
        • Northeast Iowa Medical Education Foundation
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, P.A.
      • Mission, Kansas, United States, 66202
        • Venture Resource Group, Inc.
      • Overland Park, Kansas, United States, 66209
        • Midwest Cardiology Assocaites
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Cumberland Cardiology
      • Madisonville, Kentucky, United States, 42431
        • Trover Health System
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Heart and Vascular
    • Louisiana
      • Baton Rouge, Louisiana, United States, 33437
        • Dolby Research, LLC
      • Houma, Louisiana, United States, 70301
        • Cardiovascular Institute of the South
      • Marrero, Louisiana, United States, 70072
        • Heart Clinic of Louisiana Clinical Research, LLC.
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
      • Scarborough, Maine, United States, 04074
        • Cardiovascular Consultants of Maine, PA
      • South Portland, Maine, United States, 04106
        • Maine Cardiology Associates
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Good Samaritan Hospital (Medstar Health)
      • Greenbelt, Maryland, United States, 20770
        • eCast Corporation
      • Salisbury, Maryland, United States, 21804
        • Peninsula Cardiology Associates
      • Salisbury, Maryland, United States, 21801
        • Atlantic Cardiology Associates, P.A
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • Pentucket Medical Associates
      • Natick, Massachusetts, United States, 01760
        • Charles River Medical Associates
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Michigan Cardiovascular Institute
      • Flint, Michigan, United States, 48504
        • Apex Medical Research, AMR, Inc.
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
      • Midland, Michigan, United States, 48670
        • Michigan Cardiovascular Institute
      • Saginaw, Michigan, United States, 48601
        • Michigan Cardiovascular Institute
      • Saginaw, Michigan, United States, 48602
        • Covenant Medical Center, INC.
      • St. Clair Shores, Michigan, United States, 48081
        • Academic Heart and Vascular PLLC
      • Troy, Michigan, United States, 48085
        • Oakland Medical Center
      • Waterford, Michigan, United States, 48328
        • Waterford Medical Assoc. P.C.
      • Ypsilanti, Michigan, United States, 48106
        • Michigan Heart, PC
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Duluth Clinic / Saint Marys Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • New Coast Cardiology Center, PLLC
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • PPS Clinical Research, STL, LLC
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • St. Louis, Missouri, United States, 63122
        • Cardiology Diagnostics, Ltd.
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Cardiology
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital- International Heart Institute of Montana
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • The Creighton Cardiac Center
      • Papillion, Nebraska, United States, 68046
        • Alegent Health Clinic Heart and Vascular Specialist
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Nevada Cardiology Associates
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Lahey Cardiology @ the Medical Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Associated Cardiovascular Consultants
      • Elmer, New Jersey, United States, 08318
        • Cardiovascular Associates Of The Delaware Valley, P.A.
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates Of The Delaware Valley, P.A.
      • Sewell, New Jersey, United States, 08080
        • Cardiovascular Associates Of The Delaware Valley, P.A.
      • Toms River, New Jersey, United States, 08755
        • Physicans Research Center, LLC
    • New York
      • Albany, New York, United States, 12211
        • Capital Cardiology Associates
      • Bronx, New York, United States, 10469
        • Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine
      • Cortlandt Manor, New York, United States, 10567
        • Hudson Valley Cardiology Group, P.C.
      • Johnson City, New York, United States, 13790
        • Cardiology Associates, P.C.
      • Mineola, New York, United States, 11501
        • Long Island Heart Associates
      • New Hartford, New York, United States, 13413
        • Slocum-Dickson Medical Group, Pllc
      • New Rochelle, New York, United States, 10801
        • Sound Shore Cardiology, P.C.
      • New York, New York, United States, 10001
        • New York Cardiovascular Associate
      • New York, New York, United States, 10025
        • St. Luke's- Roosevelt Hospital
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Saratoga Springs, New York, United States, 12866
        • Saratoga Cardiology Assoc, PC
      • Scarsdale, New York, United States, 10583
        • Westchester Cardiology Associates
      • Suffern, New York, United States, 10901
        • Good Samaritan Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Cardiology, PC
      • Troy, New York, United States, 12180
        • Capital Cardiology Associates
      • Williamsville, New York, United States, 14221
        • Buffalo Cardiology and Pulmonary Associates
      • Williamsville, New York, United States, 14221
        • Mark J. Kozinn, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Clinical Study Center of Asheville, LLC
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clinic, Inc.
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
      • Durham, North Carolina, United States, 27704
        • Diversified Research
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Oxford, North Carolina, United States, 27565
        • Cardiovascular Care of Northern Carolina
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • St. Alexius Medical Center
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health Systems
      • Minot, North Dakota, United States, 58701
        • Trinity Health
    • Ohio
      • Boardman, Ohio, United States, 44512
        • George G. Ellis, Jr. M.D., Inc.
      • Canton, Ohio, United States, 44710
        • Cardiovascular Research Institute, LLC
      • Cincinnati, Ohio, United States, 45236
        • Comprehensive Cardiology Consultants, Inc.
      • Columbus, Ohio, United States, 43214
        • MidWest Cardiology Research Foundation
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Zanesville, Ohio, United States, 43701
        • Cardiology Associates of SE Ohio, Inc
      • Zanesville, Ohio, United States, 43701
        • Physicans Research, Inc.
    • Oklahoma
      • Bartlesville, Oklahoma, United States, 74006
        • Bluestem Cardiology Research Dept.
      • Oklahoma City, Oklahoma, United States, 73109
        • Oklahoma Cardiovascular Research Group
      • Yukon, Oklahoma, United States, 73099
        • Aquilo Research
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Hillsboro, Oregon, United States, 97123
        • Hillsboro Cardiology, PC
      • Portland, Oregon, United States, 97210
        • Legacy Clinical Research
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Medical Specialists
      • Beaver, Pennsylvania, United States, 15009
        • Tri-State Medical Group
      • Camp Hill, Pennsylvania, United States, 17011
        • Heritage Cardiology Association
      • Easton, Pennsylvania, United States, 18042
        • Premier Heart Specialists
      • Ephrata, Pennsylvania, United States, 17522
        • Heart Specialists of Lancaster
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Jenkintown, Pennsylvania, United States, 19046
        • Pennsylvania Heart and Vascular Group, P.C.
      • Langhorne, Pennsylvania, United States, 19047
        • Comprehensive Cardiology Consultants
      • Leetsdale, Pennsylvania, United States, 15056
        • Sewickley Valley Medical Group Cardiology
      • Norristown, Pennsylvania, United States, 19401
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19148
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania Cardiology Department
      • Philadelphia, Pennsylvania, United States, 19111
        • Cardiology Consultants of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Scranton, Pennsylvania, United States, 18501
        • Advanced Cardiology Specialists
      • Sellersville, Pennsylvania, United States, 18960
        • Elite Medical Research, Inc.
      • Upland, Pennsylvania, United States, 19013
        • Cardiology Consultants of Philadelphia
      • West Chester, Pennsylvania, United States, 19380
        • West Chester Cardiology, Pc
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Cardiology, Ltd.
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research, Inc
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Cardiology
      • Westerly, Rhode Island, United States, 02891
        • Cardiology Specialists
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Athens, Tennessee, United States, 37303
        • McMinn Medical Group (DBA: Athens Medical Group)
      • Bartlett, Tennessee, United States, 38134
        • Verzosa & Ungab Internal Medicine Associates
      • Fayetteville, Tennessee, United States, 37334
        • Middle Tennessee Clinical Research
      • Jackson, Tennessee, United States, 38301
        • Research Associates of Jackson and Apex Cardiology
      • Johnson City, Tennessee, United States, 37601
        • Tri-State Cardiology
      • Memphis, Tennessee, United States, 38119
        • Memphis Internal Medicine
      • Memphis, Tennessee, United States, 38120
        • Goodlife Medical Center
      • Nashville, Tennessee, United States, 37203
        • Heart and Vascular Clinic
    • Texas
      • Arlington, Texas, United States, 76013
        • Family Health Care Assoc.
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Clinical Research Center
      • Carrollton, Texas, United States, 75006
        • Trinity Hypertension and Diagnostic Res.
      • Dallas, Texas, United States, 75216
        • VA Medical Center
      • Dallas, Texas, United States, 75390
        • U.T. Southwestern
      • Fort Worth, Texas, United States, 76104
        • Amir Malik Research
      • Galveston, Texas, United States, 77555-0553
        • The University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77024
        • Comprehensive Heart Care, PA
      • Houston, Texas, United States, 77002
        • East Texas Cardiology PA
      • Houston, Texas, United States, 77036
        • Century Clinical Research
      • Houston, Texas, United States, 77004
        • Office of Amer Zaheer, MD
      • Houston, Texas, United States, 77008
        • Office of Salim Gopalani, MD
      • Houston, Texas, United States, 77055
        • Office of Mizra Basith Baig, MD
      • Lubbock, Texas, United States, 79410
        • Covenant Cardiology Associates
      • Mcallen, Texas, United States, 78572
        • South Texas Institutes of Health
      • Plano, Texas, United States, 75024
        • Texas Regional Heart Center d/b/a Legacy Heart Center
      • San Antonio, Texas, United States, 78229
        • Cardiology Clinic of San Antonio
      • San Antonio, Texas, United States, 78229
        • South Texas Cardiovascular Consultants
      • San Antonio, Texas, United States, 78217
        • Heart & Vascular Institute of Texas
      • San Antonio, Texas, United States, 78258
        • IMED Research, PA
      • Sugar Land, Texas, United States, 77478
        • Southwest Health Associate, PA
      • Sugarland, Texas, United States, 77479
        • Office of Dwayne O. Williams, MD
      • Temple, Texas, United States, 76502
        • Kings Daughters Clinic
      • Victoria, Texas, United States, 77901
        • Victoria Heart and Vascular Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Cardiology Consultants of Danville
      • Galax, Virginia, United States, 24333
        • Triad Research Institute
      • Richmond, Virginia, United States, 23226
        • Virginia Cardiovascular Specialists
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center/ Clinical Research Department
    • Washington
      • Burien, Washington, United States, 98166
        • Daniel W. Gottlieb, Md, Ps
      • Spokane, Washington, United States, 99204
        • Heart Clinic Northwest
      • Spokane, Washington, United States, 99204
        • Inland Cardiology Assocaites
      • Tacoma, Washington, United States, 98405
        • Franciscan Health System dba FHS Research Center
    • West Virginia
      • Parkersburg, West Virginia, United States, 26101
        • Parkersburg Cardiology Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Wisconsin Heart, S.C.
      • Milwaukee, Wisconsin, United States, 53215
        • Heart Care Associates, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in whom a requirement for clopidogrel therapy with concomitant aspirin is anticipated for at least the next 12 months. Specific conditions that may confer a need for long-term clopidogrel + aspirin therapy may include non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acute MI), or new placement of a coronary artery stent.
  • For women of childbearing potential, negative pregnancy test prior to randomization and agreement to use effective method of birth control during the study.
  • Able to provide written informed consent based on competent mental status.

Exclusion Criteria:

  • Patients currently hospitalized for whom discharge is not anticipated within 48 hours of randomization.
  • Requirement for current or chronic use of a proton pump inhibitor, H2 receptor blocker, sucralfate or misoprostol.
  • Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastric surgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do not currently require proton pump blockers will be eligible.
  • Receipt of > 21 days of clopidogrel or another thienopyridine prior to randomization.
  • Oral anticoagulation that cannot be safely discontinued for duration of study.
  • Recent fibrinolytic therapy.
  • Scheduled percutaneous coronary intervention (PCI). Patients may be enrolled upon completion of PCI.
  • Recent (< 30 days prior to randomization) or scheduled coronary artery bypass graft (CABG) surgery.
  • Cardiogenic shock at time of randomization, refractory ventricular arrhythmias, or congestive heart failure (NY Heart Association class IV).
  • Active pathological bleeding or a history of hereditary or acquired hemostatic disorder.
  • History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm.
  • Systemic corticosteroids except low-dose oral corticosteroids equivalent to prednisone < or equal to 5 mg/day.
  • Allergy or contraindication to clopidogrel or other thienopyridine drugs, omeprazole or other proton pump inhibitor drugs, aspirin or salicylate derivatives, or other study drug ingredients.
  • Treatment within 30 days prior to randomization with any investigational drug or device including investigational coronary artery stents or currently enrolled in another interventional drug or device study.
  • Women who are pregnant or breastfeeding.
  • Life expectancy less than 12 months.
  • Laboratory abnormality at screening that is clinically significant or outside protocol-allowed limits, or any other condition that precludes participation in the study in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
Active Comparator: 2
(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study
Composite of gastroduodenal bleeding, obstruction or perforation
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study
Discontinuation of study medication attributed to gastrointestinal signs or symptoms
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study
Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study
Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study
Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke
Time Frame: Anticipated minimum of 48 weeks, up to end of study
Anticipated minimum of 48 weeks, up to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pablo Lapuerta, MD, Cogentus Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 12, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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