Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD (BETonMACE)

July 23, 2021 updated by: Resverlogix Corp

A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)

The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The majority (75%) of deaths in subjects with diabetes mellitus (DM) are due to atherosclerotic cardiovascular disease (CVD). Recent studies suggest a major adverse cardiovascular event (MACE) rate of >11% over 18 months in type 2 diabetes mellitus (T2DM) despite a baseline LDL-C of <2.1 mmol/L. Bromodomains (BRDs) are a family of evolutionary conserved protein-interaction modules that play key functions in chromatin organization and regulation of gene transcription. One recognized family of bromodomain-containing proteins is the bromodomain and extra-terminal (BET) family. BET inhibition represents a novel, epigenetic approach to treat CAD.

RVX000222 affects biological processes important in atherosclerosis and acute coronary events via selective inhibition of BET proteins. RVX000222 is available as a capsule formulation with standard excipients and established stability.

The BETonMACE study will focus on prevention of subsequent MACE in subjects with CAD and DM with high intensity statin therapy as co-medication.

Study Type

Interventional

Enrollment (Actual)

2425

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

  • Argentina
      • Bahía Blanca, Argentina
        • Instituto de Investigaciones Clínicas Bahia Blanca
      • Buenos Aires, Argentina
        • Sanatorio Güemes
      • Buenos Aires, Argentina
        • Bioclinica Buenos Aires
      • Buenos Aires, Argentina
        • Centro Privado de Enfermedades Cardiovasculares
      • Buenos Aires, Argentina
        • Consultorios Asociados Endocronología E Investigación Clínica Aplicada
      • Buenos Aires, Argentina
        • Instituto Cardiovascular de Buenos Aires
      • Coronel Suárez, Argentina
        • Clínica Coronel Suarez
      • Corrientes, Argentina
        • Instituto de Cardiologia de Corrientes Juana Francisca Cabral
      • Córdoba, Argentina
        • Hospital San Roque
      • Córdoba, Argentina
        • Sanatorio Allende
      • Córdoba, Argentina
        • CEMAIC
      • Córdoba, Argentina
        • Centro Médico Colón
      • Córdoba, Argentina
        • Centro Medico Luquez
      • Córdoba, Argentina
        • Clínica Privada Del Prado Sociedad de Responsabilidad Limitada
      • Córdoba, Argentina
        • Fundacion Clinica Colombo
      • Córdoba, Argentina
        • Hospital Córdoba
      • Córdoba, Argentina
        • Instituto del Corazon
      • Córdoba, Argentina
        • Instituto Modelo de Cardiologia
      • Córdoba, Argentina
        • Instituto Medico DAMIC
      • Córdoba, Argentina
        • Ipac Caraffa
      • Haedo, Argentina
        • Centro Médico Libertad
      • Lanús, Argentina
        • CIMEL
      • Mar Del Plata, Argentina
        • Instituto de Investigaciones Clínicas Mar del Plata
      • Mendoza, Argentina
        • Hospital Central
      • Ramos Mejia, Argentina
        • DIM Clínica Privada
      • Rosario, Argentina
        • Instituto de Hematologia Y Medicina Clinica
      • Rosario, Argentina
        • Sanatorio Britanico de Rosario
      • Salta, Argentina
        • Prevencion Cardio Vascular
      • San Isidro, Argentina
        • Grupo Medico Alem
      • San Miguel De Tucumán, Argentina
        • Bioclinica Tucumán
      • San Miguel De Tucumán, Argentina
        • Centro Modelo de Cardiologia
      • San Miguel De Tucumán, Argentina
        • Investigaciones Clínicas Tucumán
      • Santa Fe, Argentina
        • Centro de Investigaciones Clinicas del Litoral SRL
      • Santiago Del Estero, Argentina
        • Sanatorio San Francisco
      • Villa María, Argentina
        • Clínica FUSAVIM Privada
      • Zárate, Argentina
        • Instituto de Investigaciones Clínicas Zárate
  • Australia
      • Bedford Park, Australia
        • Flinders Medical Centre
  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Bonheiden, Belgium
        • Imelda VZW
      • Turnhout, Belgium
        • AZ Turnhout
  • Bulgaria
      • Gabrovo, Bulgaria
        • Multiprofile Hospital For Active Treatment Dr Tota Venkova
      • Lovech, Bulgaria
        • Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
      • Pazardzhik, Bulgaria
        • Multiprofile Hospital For Active Treatment - Pazardzhik AD
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
      • Smolyan, Bulgaria
        • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
      • Sofia, Bulgaria
        • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
      • Sofia, Bulgaria
        • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
      • Sofia, Bulgaria
        • City Clinic University Multiprofile Hospital for Active Treatment EOOD
      • Sofia, Bulgaria
        • Medical Center Kardiohelp EOOD
      • Sofia, Bulgaria
        • Second Multiprofile Hospital for Active Treatment Sofia
      • Sofia, Bulgaria
        • Synexus Affiliate - Diagnostic and Consulting Center Ascendent
      • Sofia, Bulgaria
        • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
      • Stara Zagora, Bulgaria
        • Medical Center Orfey OOD
      • Varna, Bulgaria
        • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • Croatia
      • Karlovac, Croatia
        • General Hospital Karlovac
      • Krapinske Toplice, Croatia
        • Special Hospital for medicinal rehabilitation Krapinske Toplice
      • Osijek, Croatia
        • Clinical Hospital Osijek
      • Slavonski Brod, Croatia
        • General Hospital Dr Josip Bencevic
      • Virovitica, Croatia
        • General Hospital Virovitica
      • Zagreb, Croatia
        • Clinical Hospital Sveti Duh
  • Germany
      • Berlin, Germany
        • DRK Kliniken Berlin Westend
      • Chemnitz, Germany
        • Medizinisches Versorgungszentrum am Küchwald GmbH
      • Dresden, Germany
        • Zentrum für Klinische Prüfung in der Facharztzentrum Dresden Neustadt Gbr
      • Erfurt, Germany
        • Katholisches Krankenhaus St. Johann Nepomuk
      • Heidelberg, Germany
        • Heidelberger Praxisklinik für Kardiologie
      • Hoyerswerda, Germany
        • Klinikum Hoyerswerda
      • Kassel, Germany
        • Studienzentrum Dr.Appel
      • Langen, Germany
        • Asklepios Klinik Langen
      • Leverkusen, Germany
        • Klinikum Leverkusen GmbH
  • Hungary
      • Baja, Hungary
        • Bajai Szent Rókus Kórház
      • Berettyóújfalu, Hungary
        • Grof Tisza Istvan Korhaz Berettyoujfalu
      • Budapest, Hungary
        • Magyar Honvédség Egészségügyi Központ
      • Budapest, Hungary
        • Szent Margit Kórház
      • Budapest, Hungary
        • Semmelweis Egyetem
      • Budapest, Hungary
        • Bajcsy-Zsilinszky Kórház és Rendelőintézet
      • Budapest, Hungary
        • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
      • Budapest, Hungary
        • Gottsegen György Országos Kardiológiai Intézet
      • Budapest, Hungary
        • Synexus (DRS) - Synexus Magyarország Kft. Budapest
      • Budapest, Hungary
        • Szent Rókus Kórház és Intézményei
      • Komárom, Hungary
        • Selye János Kórház
      • Mosonmagyaróvár, Hungary
        • TaNaMed Kft.
      • Nagykanizsa, Hungary
        • Kanizsai Dorottya Korhaz
      • Pécs, Hungary
        • Coromed-Smo Kft.
      • Szeged, Hungary
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
      • Szekszárd, Hungary
        • Tolna Megyei Balassa Janos Korhaz
      • Székesfehérvár, Hungary
        • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Be'er Sheva, Israel
        • Soroka University Medical Centre
      • Hadera, Israel
        • Hillel Yaffe Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Lady Davis Carmel Medical Center
      • Haifa, Israel
        • Bnei Zion Medical Center
      • Haifa, Israel
        • Linn Medical Center Clalit Health Services
      • Holon, Israel
        • Edith Wolfson Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Hadassah University Hospital Mount Scopus
      • Jerusalem, Israel
        • Hadassah University Hospital Ein Kerem
      • Kefar-Sava, Israel
        • Meir Medical Center
      • Nahariya, Israel
        • Galilee Medical Center
      • Nazareth, Israel
        • Nazareth EMMS Hospital
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Safed, Israel
        • ZIV Medical Center
      • Tel Aviv, Israel
        • Clalit Health Medical Center
      • Tel-Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Tiberias, Israel
        • Baruch Padeh Poriya Medical Center
  • Mexico
      • Aguascalientes, Mexico
        • Hospital Cardiologica Aguascalientes
      • Aguascalientes, Mexico
        • Fundacion Cardiovascular de Aguascalientes AC
      • Chihuahua, Mexico
        • Investigación en Salud y Metabolismo S.C.
      • Ciudad De México, Mexico
        • Clinica Integral del Paciente Diabético y Obeso
      • Ciudad de México, Mexico
        • Centro de Investigación Biomedica y Farmaceutica
      • Ciudad de México, Mexico
        • Fundación de Atención e Investigación Médica Lindavista S.C.
      • Culiacan, Mexico
        • Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
      • Durango, Mexico
        • Centro de Investigacion y Atencion de Diabetes, Endocrinologia y Nutricion
      • Guadalajara, Mexico
        • Arechavaleta Granell María del Rosario
      • Guadalajara, Mexico
        • Centro de Investigacion Medica Biologica Y de Terapia Avanzada SC
      • Guadalajara, Mexico
        • Unidad de Investigacion Clinica Cardiometabolica de Occidente SC
      • León De Los Aldama, Mexico
        • Hospital Angeles Leon
      • Merida, Mexico
        • Centro de Desarrollo Biomédico
      • Mexico City, Mexico
        • Sanatorio y Servicios Médicos Obregón S.A. de C.V.
      • Monclova, Mexico
        • Instituto Cardiovascular de Monclova
      • Monterrey, Mexico
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
      • Monterrey, Mexico
        • IMED Internal Medicine Clin Trials
      • Monterrey, Mexico
        • Unidad de Investigación Clínica En Medicina SC
      • Pachuca, Mexico
        • Diabetes Total, S.A de C.V.
      • Pachuca, Mexico
        • Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.
      • San Luis Potosi, Mexico
        • Cardioarritmias e Investigación S.C.
      • San Luis Potosí, Mexico
        • Hospital Central Dr Ignacio Morones Prieto
      • Toluca, Mexico
        • INBIOMEDYC Toluca
      • Veracruz, Mexico
        • Centro de Alta Especialidad Dr. Rafael Lucio
      • Zapopan, Mexico
        • Dr. Humberto Alvarez Lopez
  • Netherlands
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Amsterdam, Netherlands
        • OLVG locatie Oost
  • Poland
      • Bialystok, Poland
        • Podlaski Osrodek Kardiologii Poradnia Prywatna
      • Chrzanow, Poland
        • Malopolskie Centrum Sercowo-Naczyniowe
      • Dabrowa Gornicza, Poland
        • Polsko-Amerykańskie Kliniki Serca
      • Gdynia, Poland
        • Gabinet Kardiologiczno-Internistyczny
      • Kielce, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med.
      • Kraków, Poland
        • Diamond Clinic
      • Kraków, Poland
        • Szpital Specjalistyczny im. Jozefa Dietla w Krakowie
      • Kraków, Poland
        • Zespol Przychodni Specjalistycznych DIAB-END-COR Sp. z o.o.
      • Lodz, Poland
        • Prywatna Praktyka Lekarska MAZ-MEDICA Maciej R.Mazurkiewicz
      • Lódz, Poland
        • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
      • Nysa, Poland
        • Polsko-Amerykańskie Kliniki Serca
      • Opole, Poland
        • Pro Corde, Dom Medyczny
      • Oswiecim, Poland
        • Medicome Sp. z o.o.
      • Otwock, Poland
        • Rodzinne Centrum Zdrowia
      • Plock, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"
      • Tarnobrzeg, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB
      • Warszawa, Poland
        • Centrum Medyczne doktorA
      • Warszawa, Poland
        • Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
      • Warszawa, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej AURUM
      • Wroclaw, Poland
        • Centrum Kardiologiczne Pro Corde Sp. z o.o. Niepubliczny Zaklad Opieki Zdrowotnej
      • Wroclaw, Poland
        • Wro Medica
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • City Clinical Hospital #6
      • Ekaterinburg, Russian Federation
        • Ural State Medical University
      • Kemerovo, Russian Federation
        • Federal Budget Healthcare Institution Medici - sanitary unit of Ministry of internal affairs of Russ
      • Kemerovo, Russian Federation
        • Research Institute of Complex Cardiovascular Pathology
      • Krasnodar, Russian Federation
        • Krasnodar Regional Clinical Hospital #2
      • Moscow, Russian Federation
        • Russian Cardiology Research and Production Center
      • Moscow, Russian Federation
        • Moscow City State Budgetary Healthcare Institution City Clinical Hospital named after V.V. Veresayev
      • Nizhniy Novgorod, Russian Federation
        • City Hospital 13
      • Novosibirsk, Russian Federation
        • State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital No. 19
      • Petrozavodsk, Russian Federation
        • Republican Hospital n.a. V.A. Baranov
      • Rostov-on-Don, Russian Federation
        • Municipal Budgetary Healthcare Institution City Emergency Hospital
      • Saint Petersburg, Russian Federation
        • International Medical Center SOGAZ
      • Saint Petersburg, Russian Federation
        • North-West State Medical University n.a. I.I. Mechnikov
      • Saint Petersburg, Russian Federation
        • St Petersburg City Outpatient Clinic #109
      • Saratov, Russian Federation
        • Saratov State Medical University
      • Saratov, Russian Federation
        • State Healthcare Institution Regional Clinical Cardiologic Dispensary
      • Sochi, Russian Federation
        • City Hospital #4
      • Tomsk, Russian Federation
        • Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch
      • Vladimir, Russian Federation
        • State Budgetary Healthcare Institution of Vladimir Region City Hospital No. 4
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Military Medical Academy
      • Belgrade, Serbia
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia
        • Clinical Hospital Centar Zvezdara
      • Belgrade, Serbia
        • Clinical Hospital Centre Zemun
      • Belgrade, Serbia
        • Euromedik
      • Belgrade, Serbia
        • Institute of Cardiovascular Diseases Dedinje
      • Belgrade, Serbia
        • KBC Dr Dragisa Misovic Dedinje
      • Kragujevac, Serbia
        • Clinical Center Kragujevac
      • Nis, Serbia
        • Clinical Center Nis
      • Niska Banja, Serbia
        • Institute Niska Banja
      • Novi Sad, Serbia
        • Clinical Centre of Vojvodina
      • Sremska Kamenica, Serbia
        • Institute of Cardiovascular Diseases of Vojvodina
      • Uzice, Serbia
        • General Hospital Uzice
      • Zajecar, Serbia
        • Health Center Zajecar
  • Slovakia
      • Bardejov, Slovakia
        • ALIAN, s.r.o
      • Bratislava, Slovakia
        • Univerzitna nemocnica Bratislava
      • Bratislava, Slovakia
        • CARDIOCONSULT, s.r.o.
      • Dolny Kubin, Slovakia
        • Kardio-Onkologia, s.r.o.
      • Kosice, Slovakia
        • Cardio D&R, S.R.O. Kosice
      • Kosice, Slovakia
        • Zeleznicne zdravotnictvo Kosice, s.r.o.
      • Lucenec, Slovakia
        • KardioMed s.r.o.
      • Moldava nad Bodvou, Slovakia
        • MEDI M&M s.r.o.
      • Nove Mesto nad Vahom, Slovakia
        • Nemocnica s poliklinikou Nove Mesto nad Vahom n.o.
      • Nove Zamky, Slovakia
        • Cardioinvest s. r. o.
      • Roznava, Slovakia
        • DIAB s.r.o.
      • Zilina, Slovakia
        • MEDIVASA, s.r.o.
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taiwan
        • Mackay Memorial Hospital-Taipei Branch
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan City, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • Cathay General Hospital
      • Taipei, Taiwan
        • Chi Mei Medical Center
      • Taipei City, Taiwan
        • Tri-Service General Hospital
      • Taoyuan City, Taiwan
        • Chang Gung Medical Foundation Linkou Branch (Clinical Research Center)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• ACS event of either unstable angina or myocardial infarction 7-90 days prior Visit 1:

Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and (c) must be satisfied: a.) Characteristic ischemic pain or discomfort in chest/associated referral areas, occurring at rest/with minimal exertion b.) ECG changes consistent with acute myocardial ischemia based on new/presumed ST elevation/depression or T-wave inversion c.) Objective evidence of obstructive CAD based on 1+ of the following: i. New/presumed new evidence of myocardial ischemia/infarction by perfusion imaging ii. New/presumed new regional wall motion abnormality iii. Current evidence of at least 1 epicardial coronary artery stenosis ≥70% by coronary angiography iv. Need for coronary revascularization for the index ACS event, including a percutaneous coronary intervention (PCI) with or without coronary stenting.

Prior MI 7-90 days prior screening treated with or without a percutaneous coronary intervention (PCI). For a qualifying event of MI 2 of the following 3 criteria must be satisfied: a.) Characteristic ischemic chest pain/pain in associated referral areas b.) Dynamic elevation of troponin T/I or CKMB if troponinT/I is unavailable at local lab (at least >ULN for lab) c.) Development of new Q-waves in ≥2 adjacent ECG leads or development of new dominant R wave in V1

  • Documented diagnosis of T2DM (1+ of the following criteria): Documented history of T2DM, History of taking diabetes medication, and/or HbA1c ≥6.5% at Visit 1
  • For males HDL-C<40 mg/dL(1.04 mmol/L), for females HDL-C<45 mg/dL(1.17 mmol/L) at Visit 1
  • Subjects currently not on high intensity statin therapy could start rosuvastatin at Visit 1 and those currently on therapy besides atorvastatin/rosuvastatin can be switched to rosuvastatin at Visit 1
  • Female subjects of non-childbearing potential (post-surgical sterilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or diaphragm) or remain abstinent from Screening to Follow-up Visit
  • Give signed informed consent

Exclusion Criteria:

  • Heart disease which will w/in 90 days of Visit 1 likely need coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement
  • Previous/current diagnosis of severe heart failure or documented LVEF<25% determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. Absence of LVEF measurement in subject w/out a previous/current diagnosis of heart failure does not exclude entry into study
  • Evidence of cardiac EP instability incl. history of uncontrolled ventricular arrhythmias, atrial fibrillation/flutter or supraventricular tachycardias w/ a ventricular response HR>100bpm at rest w/in 4 wks prior Visit 1
  • CABG w/in 90 days prior Visit 1
  • Evidence of severe renal impairment as determined by either eGFR<30 mL/min/1.7m2 at Visit 1 or current need for dialysis
  • Uncontrolled hypertension defined as 2 consecutive measurements of sitting BP of systolic>180 mmHg or diastolic>100 mmHg at Visit 1
  • Treatment w/ immunosuppressants w/in 12 mos prior Visit 1
  • Use of fibrates at any dose or niacin/nicotinic acid 250+ mg w/in 30 days prior Visit 1
  • Known allergy/sensitivity to any ingredient in IMP
  • History of intolerance to atorvastatin/rosuvastatin
  • Triglycerides>400 mg/dL (4.52 mmol/L) at Visit 1
  • Any medical/surgical condition which might significantly alter absorption, distribution, metabolism or excretion of medication
  • Evidence of cirrhosis from liver imaging/biopsy, history of hepatic encephalopathy, esophageal/gastric varices, active hepatitis or prior porta-caval shunt procedure or a Child-Pugh score of ≥5 points
  • ALT/AST>1.5xULN by central lab at Visit 1
  • Tot. bilirubin>ULN by central lab at Visit 1
  • History of malignancy of any organ syst treated/untreated w/in the past 2 yrs whether or not there is evidence of local recurrence/metastases except localized basal skin cell carcinoma
  • History/evidence of drug/alcohol abuse w/in 12 mos of Visit 1
  • Pregnancy
  • Any condition which may place subject at higher risk from his/her participation in the study or is likely to prevent subject from completing/complying w/ requirements of study
  • Use of other investigational drugs and devices w/in 30 days or 5 half-lives of Visit 1, whichever is longer
  • History of noncompliance to medical regimens or unwillingness to comply w/ study protocol
  • Any condition that would confound the evaluation/interpretation of efficacy and/or safety data
  • Persons directly involved in execution of this protocol

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Intensity statin therapy+RVX000222
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Drug: Apabetalone
100 mg capsule
Other Names:
  • RVX000222
Drug: Atorvastatin
High-Intensity Statin
Other Names:
  • Lipitor
Drug: Rosuvastatin
High-Intensity Statin
Other Names:
  • Crestor
Active Comparator: High-Intensity statin therapy+Placebo
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Drug: Atorvastatin
High-Intensity Statin
Other Names:
  • Lipitor
Drug: Rosuvastatin
High-Intensity Statin
Other Names:
  • Crestor
Drug: Placebo
Capsule manufactured to mimic RVX000222 100 mg capsule
Other Names:
  • Placebo (for RVX000222)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Time Frame: 120 weeks
Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
120 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Time Frame: 120 weeks
First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
120 weeks
Incidence of Hospitalization for Congestive Heart Failure (CHF)
Time Frame: 120 weeks
120 weeks
Incidence of All-cause Mortality
Time Frame: 120 weeks
120 weeks
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Time Frame: 120 weeks
120 weeks
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Time Frame: 172 weeks
172 weeks
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame: 52 weeks
52 weeks
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Time Frame: 120 weeks
120 weeks

Collaborators and Investigators

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

Sponsor

Resverlogix Corp

Collaborators

PPD
ICON plc
Medidata Solutions

Investigators

  • Study Chair: Kausik Ray, MD, Imperial College London

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.

General Publications

Helpful Links

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 (Actual)

November 1, 2015

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

June 21, 2021

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVX222-CS-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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