Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI)

Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: BAY2433334; Other: BAY2433334 matching placebo

• Study Type: Interventional
• Enrollment (Actual): 1601
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Wien, Austria, 1160
    • Klinik Ottakring - Wilhelminenspital
  • Wien, Austria, 1210
    • Klinik Floridsdorf - Krankenhaus Nord
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
      • Klinikum Klagenfurt am Wörthersee
  • Niederösterreich
    • St. Pölten, Niederösterreich, Austria, 3100
      • Universitätsklinikum St. Pölten
    • Wiener Neustadt, Niederösterreich, Austria, 2700
      • Landesklinikum Wiener Neustadt
  • Oberösterreich
    • Braunau, Oberösterreich, Austria, 5280
      • Krankenhaus St. Josef Braunau
    • Linz, Oberösterreich, Austria, 4021
      • Kepler Universitätsklinikum Campus III
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Aalst, Belgium, 9300
    • OL Vrouwziekenhuis - Campus Aalst
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis - St-Elisabethkliniek
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
  • Bruxelles - Brussel, Belgium, 1200
    • CU Saint-Luc/UZ St-Luc
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liege, Belgium, 4000
    • CHR de la Citadelle - Cardiology
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny
  • Brno, Czechia, 625 00
    • Fakultní Nemocnice Brno
  • Ceske Budejovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice, a.s. Department of kardiologie
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Plzen, Czechia, 304 60
    • Fakultni nemocnice Plzen - Lochotin
  • Praha 10, Czechia, 10034
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Praha 4, Czechia, 140 21
    • Institut Klinicke A Experimentalni Mediciny
  • Praha 5, Czechia, 150 06
    • Fakultni Nemocnice v Motole
  • Praha 6, Czechia, 169 02
    • Ústřední Vojenská Nemocnice Praha
  • Slany, Czechia, 274 01
    • Nemocnice Slany
• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg Eppendorf (UKE)
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Baden-Württemberg
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
      • Universitätsherzzentrum Freiburg - Bad Krozingen
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
    • Köln, Nordrhein-Westfalen, Germany, 50733
      • St. Vinzenz-Hospital
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
      • Kliniken Maria Hilf GmbH
    • Remscheid, Nordrhein-Westfalen, Germany, 42859
      • Sana-Klinikum Remscheid GmbH
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • Forschungszentrum Ruhr - KliFoCenter GmbH
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg Universität Mainz
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • Krankenhaus Dresden-Friedrichstadt
• Hungary
  • Balatonfured, Hungary, 8230
    • Állami Szívkorhaz
  • Budapest, Hungary, 1023
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1122
    • University of Semmelweis/ Semmelweis Egyetem
  • Budapest, Hungary
    • Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyor, Hungary, 9023
    • Petz Aladár Megyei Oktató Kórház
  • Gyula, Hungary, 5700
    • Pandy Kalman Korhaz
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház
  • Nyiregyhaza, Hungary, H-4400
    • Josa Andras Hospital
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Kórház
• Italy
  • Campania
    • Benevento, Campania, Italy, 82100
      • A.O. San Pio
    • Caserta, Campania, Italy, 81031
      • ASL Caserta
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44124
      • A.O.U. di Ferrara
  • Lazio
    • Roma, Lazio, Italy, 00157
      • Asl Roma 2
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Ospedale Policlinico San Martino
  • Lombardia
    • Milano, Lombardia, Italy, 20089
      • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
    • Milano, Lombardia, Italy, 20138
      • IRCCS Centro Cardiologico Monzino S.p.A
    • Varese, Lombardia, Italy, 21047
      • ASST Valle Olona
  • Marche
    • Ancona, Marche, Italy, 60126
      • A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
  • Piemonte
    • Cuneo, Piemonte, Italy, 12100
      • A.O. S.Croce e Carle
    • Torino, Piemonte, Italy, 10098
      • ASL TO3 di Collegno e Pinerolo
  • Sardegna
    • Sassari, Sardegna, Italy
      • A.O.U. di Sassari
  • Toscana
    • Grosseto, Toscana, Italy, 58100
      • AUSL Toscana Sud-Est
  • Veneto
    • Venezia, Veneto, Italy, 30035
      • ULSS3 Serenissima
• Japan
  • Fukui, Japan, 910-8526
    • Fukui Prefectural Hospital
  • Fukuoka, Japan, 815-8555
    • Japanese Red Cross Fukuoka Hospital
  • Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Oita, Japan, 870-8511
    • Oita Prefectural Hospital
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Aichi
    • Nagoya, Aichi, Japan, 457-8511
      • Daido Hospital, Social Medical Corporation Kojunkai
  • Chiba
    • Matsudo, Chiba, Japan, 270-2251
      • Chiba-Nishi General Hospital
  • Fukuoka
    • Kasuga, Fukuoka, Japan, 816-0864
      • Fukuoka Tokushukai Hospital
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Gifu
    • Ogaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-8622
      • Hokkaido Cardiovascular Hospital
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8560
      • Hyogo Prefectural Harima-Himeji General Medical Center
    • Kobe, Hyogo, Japan, 654-0026
      • Takahashi Hospital
    • Nishinomiya, Hyogo, Japan, 662-0911
      • Nishinomiya Watanabe Cardiovascular Center
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8558
      • Tsukuba Medical Center Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center
  • Osaka
    • Kishiwada, Osaka, Japan, 596-0042
      • Kishiwada Tokushukai Hospital
  • Saitama
    • Kuki, Saitama, Japan, 346-8530
      • Shin-Kuki General Hospital
    • Sayama, Saitama, Japan, 350-1305
      • Saitama Sekishinkai Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University Hospital
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Gasthuis
  • Den Bosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis, Dordwijk
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Helmond, Netherlands, 5707 HA
    • Elkerliek Ziekenhuis, Lokatie Helmond
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius Wilhelmina Ziekenhuis
  • Nijmegen, Netherlands, 6500 HB
    • Universitair Medisch Centrum St. Radboud
  • Roosendaal, Netherlands, 4708 AE
    • Bravis Ziekenhuis
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis
  • Venlo, Netherlands, 5912 BL
    • VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo
  • Zutphen, Netherlands, 7207 AE
    • Gelre Ziekenhuizen Zutphen
  • Zwolle, Netherlands, 8025 AZ
    • Isala
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Gdynia, Poland, 81-348
    • Szpital sw. Wincentego a Paulo
  • Grodzisk Mazowiecki, Poland, 05-825
    • Samodzielny Publiczny Specjalistyczny Szpital Zachodni
  • Opole, Poland, 45-401
    • Uniwersytecki Szpital Kliniczny w Opolu
  • Rzeszow, Poland, 35-301
    • Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
  • Warszawa, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne Warszawskiego UM
  • Warszawa, Poland, 04-073
    • Szpital Grochowski im. dr.med. Rafala Masztaka
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
• Spain
  • Barcelona, Spain, 08035
    • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i de Sant Pau | Cardiología
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves|Cardiologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal | Cardiologia
  • Madrid, Spain, 28040
    • Hospital Clinico Universitario San Carlos | Cardiologia
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke
  • Sevilla, Spain, 41071
    • Hospital Universitario Virgen De La Macarena
  • Tarragona, Spain, 43005
    • Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia
  • Valencia, Spain, 46014
    • Hospital Gral. Univ. de Valencia | Cardiologia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe | Cardiología
• Sweden
  • Falun, Sweden, 791 82
    • Falu Lasarett
  • Göteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset
  • Jönköping, Sweden, 551 85
    • Länssjukhuset Ryhov
  • Lund, Sweden, 222 42
    • Skanes universitetssjukhus
  • Stockholm, Sweden, 182 88
    • Danderyds Sjukhus
  • Sundsvall, Sweden, 851 86
    • Länssjukhuset Sundsvall-Härnösand
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset Hjärtforskningsmottagningen
  • Västerås, Sweden, 721 89
    • Västmanlands sjukhus Västerås
  • Örebro, Sweden, 701 85
    • Universitetssjukhuset Örebro
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Genève, Switzerland, 1205
    • Hopital Cantonal Universitaire de Geneve
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau
  • Basel-Landschaft
    • Liestal, Basel-Landschaft, Switzerland, 4410
      • Kantonsspital Baselland - Standort Liestal
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (Chuv)
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Imperial College London
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Lister Hospital
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
      • Freeman Hospital
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
      • Worcestershire Acute Hospital Trust
• United States
  • California
    • Covina, California, United States, 91723
      • Valley Clinical Trials, Inc. - Covina
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Florida Premier Cardiology
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Associates | Clearwater, FL
    • Daytona Beach, Florida, United States, 32117
      • Cardiology Associates Research Company
    • Naples, Florida, United States, 34102
      • Southwest Florida Research
    • Palm Beach Gardens, Florida, United States, 33410
      • Cardiology Partners Clinical Research Institute
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Reid Health
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart & Vascular Specialists
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Cardiovascular Associates Research, LLC
    • Zachary, Louisiana, United States, 70791
      • Southern Clinical Research, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
    • Silver Spring, Maryland, United States, 20904
      • White Oak Medical Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's/Duluth Clinic Health System
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clinic
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital, Inc.
  • New York
    • Cheektowaga, New York, United States, 14227
      • Trinity Medical WNY
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Heart Institute
  • Tennessee
    • Powell, Tennessee, United States, 37849
      • Cardiovascular Research of Knoxville
  • Texas
    • Amarillo, Texas, United States, 79109
      • PharmaTex Research, LLC
    • McKinney, Texas, United States, 75071
      • North Texas Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be 45 years of age or older, at the time of signing the informed consent

• Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:

  • clinical symptoms of acute myocardial infarction AND
  • elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND

  • at least one of the following risk factors need to be fulfilled:

    • Age ≥ 65 years
    • Prior MI (before the index AMI event)
    • Prior peripheral arterial disease
    • Diabetes Mellitus
    • Prior coronary artery bypass grafting (CABG) AND
  • initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization)
• Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI
• Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.

Exclusion Criteria:

• Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization
• Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
• Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: BAY2433334 matching placebo	Other: BAY2433334 matching placebo; Tablet, taken orally once a day.
Experimental: BAY 2433334 high dose	Drug: BAY2433334; Tablet, taken orally once a day.
Experimental: BAY 2433334 medium dose	Drug: BAY2433334; Tablet, taken orally once a day.
Experimental: BAY 2433334 low dose	Drug: BAY2433334; Tablet, taken orally once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)	CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause	From baseline up to 52 weeks
Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5	Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.	From baseline up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Number of Participants With CV Death	CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.	From baseline up to 52 weeks
Efficacy - Number of Participants With MI	Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.	From baseline up to 52 weeks
Efficacy - Number of Participants With Stroke	Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.	From baseline up to 52 weeks
Efficacy - Number of Participants With Stent Thrombosis	ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause	From baseline up to 52 weeks
Efficacy - Number of Participants With All Cause Mortality		From baseline up to 52 weeks
Safety - Number of Participants With All Bleeding	All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention	From baseline up to 52 weeks
Safety - Number of Participants With BARC Bleeding Definition Type 3, 5	Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.	From baseline up to 52 weeks
Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5	Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.	From baseline up to 52 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Rao SV, Kirsch B, Bhatt DL, Budaj A, Coppolecchia R, Eikelboom J, James SK, Jones WS, Merkely B, Keller L, Hermanides RS, Campo G, Ferreiro JL, Shibasaki T, Mundl H, Alexander JH; PACIFIC AMI Investigators. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction. Circulation. 2022 Oct 18;146(16):1196-1206. doi: 10.1161/CIRCULATIONAHA.122.061612. Epub 2022 Aug 27. Erratum In: Circulation. 2022 Dec 6;146(23):e330.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 8, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 20603; 2019-003244-79 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No