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

NCT ID: NCT02586155

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-06-21

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

High-Intensity statin therapy+RVX000222

Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)

Group Type: EXPERIMENTAL

Apabetalone

Intervention Type: DRUG

100 mg capsule

Atorvastatin

Intervention Type: DRUG

High-Intensity Statin

Rosuvastatin

Intervention Type: DRUG

High-Intensity Statin

High-Intensity statin therapy+Placebo

Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule manufactured to mimic RVX000222 100 mg capsule

Atorvastatin

Intervention Type: DRUG

High-Intensity Statin

Rosuvastatin

Intervention Type: DRUG

High-Intensity Statin

Interventions

Apabetalone

100 mg capsule

Intervention Type: DRUG

Placebo

Capsule manufactured to mimic RVX000222 100 mg capsule

Intervention Type: DRUG

Atorvastatin

High-Intensity Statin

Intervention Type: DRUG

Rosuvastatin

High-Intensity Statin

Intervention Type: DRUG

Other Intervention Names

RVX000222; Placebo (for RVX000222); Lipitor; Crestor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

ICON plc

INDUSTRY

Sponsor Role: collaborator

Medidata Solutions

INDUSTRY

Sponsor Role: collaborator

Resverlogix Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kausik Ray, MD

Role: STUDY_CHAIR

Imperial College London

Locations

Instituto de Investigaciones Clinicas Bahia Blanca

Bahía Blanca, , 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

Buenos Aires, , Argentina

Sanatorio Guemes

Buenos Aires, , Argentina

Clinica Coronel Suarez

Coronel Suárez, , Argentina

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, , Argentina

CEMAIC

Córdoba, , Argentina

Centro Médico Colón

Córdoba, , Argentina

Centro Médico Luquez

Córdoba, , Argentina

Clínica Privada Del Prado Sociedad de Responsabilidad Limitada

Córdoba, , Argentina

Fundación Clínica Colombo

Córdoba, , Argentina

Hospital Cordoba

Córdoba, , Argentina

Hospital San Roque

Córdoba, , Argentina

Instituto Del Corazón

Córdoba, , Argentina

Instituto Modelo de Cardiologia

Córdoba, , Argentina

Instituto Médico DAMIC

Córdoba, , Argentina

Ipac Caraffa

Córdoba, , Argentina

Sanatorio Allende

Córdoba, , Argentina

Centro Médico Libertad

Haedo, , Argentina

CIMEL

Lanús, , Argentina

Instituto de Investigaciones Clínicas Mar Del Plata

Mar del Plata, , Argentina

Hospital Central

Mendoza, , Argentina

DIM Clinica Privada

Ramos Mejía, , Argentina

Instituto de Hematologia Y Medicina Clinica

Rosario, , Argentina

Sanatorio Britanico de Rosario

Rosario, , Argentina

Prevencion Cardio Vascular

Salta, , Argentina

Grupo Medico Alem

San Isidro, , Argentina

Bioclinica Tucumán

San Miguel de Tucumán, , Argentina

Centro Modelo de Cardiologia

San Miguel de Tucumán, , Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, , Argentina

Centro de Investigaciones Clínicas Del Litoral SRL

Santa Fe, , Argentina

Sanatorio San Francisco

Santiago del Estero, , Argentina

Clínica FUSAVIM Privada

Villa María, , Argentina

Instituto de Investigaciones Clínicas Zárate

Zárate, , Argentina

Flinders Medical Centre

Bedford Park, , Australia

ZNA Middelheim

Antwerp, , Belgium

Imelda VZW

Bonheiden, , Belgium

AZ Turnhout

Turnhout, , Belgium

Multiprofile Hospital For Active Treatment Dr Tota Venkova

Gabrovo, , Bulgaria

Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD

Lovech, , Bulgaria

Multiprofile Hospital For Active Treatment - Pazardzhik AD

Pazardzhik, , Bulgaria

University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

Pleven, , Bulgaria

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

Smolyan, , 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 Aleksandrovska EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

Sofia, , Bulgaria

Medical Center Orfey OOD

Stara Zagora, , Bulgaria

Multiprofile Hospital for Active Treatment Sveta Marina EAD

Varna, , Bulgaria

General Hospital Karlovac

Karlovac, , Croatia

Special Hospital for medicinal rehabilitation Krapinske Toplice

Krapinske Toplice, , Croatia

Clinical Hospital Osijek

Osijek, , Croatia

General Hospital Dr Josip Bencevic

Slavonski Brod, , Croatia

General Hospital Virovitica

Virovitica, , Croatia

Clinical Hospital Sveti duh

Zagreb, , Croatia

DRK Kliniken Berlin Westend

Berlin, , Germany

Medizinisches Versorgungszentrum am Küchwald GmbH

Chemnitz, , Germany

Zentrum für Klinische Prüfung in der Facharztzentrum Dresden Neustadt Gbr

Dresden, , Germany

Katholisches Krankenhaus St. Johann Nepomuk

Erfurt, , Germany

Heidelberger Praxisklinik für Kardiologie

Heidelberg, , Germany

Klinikum Hoyerswerda

Hoyerswerda, , Germany

Studienzentrum Dr.Appel

Kassel, , Germany

Asklepios Klinik Langen

Langen, , Germany

Klinikum Leverkusen GmbH

Leverkusen, , Germany

Bajai Szent Rókus Kórház

Baja, , Hungary

Grof Tisza Istvan Korhaz Berettyoujfalu

Berettyóújfalu, , Hungary

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Budapest, , Hungary

Gottsegen Gyorgy Orszagos Kardiologiai Intezet

Budapest, , Hungary

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Synexus (DRS) - Synexus Magyarország Kft. Budapest

Budapest, , Hungary

Szent Margit Korhaz

Budapest, , Hungary

Szent Rókus Kórház és Intézményei

Budapest, , Hungary

Selye János Kórház

Komárom, , Hungary

TaNaMed Kft.

Mosonmagyaróvár, , Hungary

Kanizsai Dorottya Kórház

Nagykanizsa, , Hungary

Coromed-SMO Kft.

Pécs, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Tolna Megyei Balassa János Kórház

Szekszárd, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Barzilai Medical Center

Ashkelon, , Israel

Soroka University Medical Centre

Beersheba, , Israel

Hillel Yaffe Medical Center

Hadera, , Israel

Bnei Zion Medical Center

Haifa, , Israel

Lady Davis Carmel Medical Center

Haifa, , Israel

Linn Medical Center Clalit Health Services

Haifa, , Israel

Rambam Medical Center

Haifa, , Israel

Edith Wolfson Medical Center

Holon, , Israel

Hadassah University Hospital Ein Kerem

Jerusalem, , Israel

Hadassah University Hospital Mount Scopus

Jerusalem, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Meir Medical Center

Kefar Sava, , Israel

Galilee Medical Center

Nahariya, , Israel

Nazareth EMMS Hospital

Nazareth, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

ZIV Medical Center

Safed, , Israel

Clalit Health Medical Center

Tel Aviv, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Baruch Padeh Poriya Medical Center

Tiberias, , Israel

Fundacion Cardiovascular de Aguascalientes AC

Aguascalientes, , Mexico

Hospital Cardiológica Aguascalientes

Aguascalientes, , Mexico

Investigacion en Salud y Metabolismo S.C.

Chihuahua City, , Mexico

Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC

Culiacán, , Mexico

Centro de Investigacion y Atencion de Diabetes, Endocrinologia y Nutricion

Durango, , Mexico

Arechavaleta Granell Maria del Rosario

Guadalajara, , Mexico

Centro de Investigacion Medica Biologica Y de Terapia Avanzada SC

Guadalajara, , Mexico

Unidad de Investigacion Clinica Cardiometabolica de Occidente SC

Guadalajara, , Mexico

Hospital Angeles Leon

León, , Mexico

Centro de Investigación Biomedica y Farmaceutica

Mexico City, , Mexico

Clinica Integral del Paciente Diabetico y Obeso

Mexico City, , Mexico

Fundación de Atención e Investigación Médica Lindavista S.C.

Mexico City, , Mexico

Sanatorio y Servicios Médicos Obregón S.A. de C.V.

Mexico City, , Mexico

Centro de Desarrollo Biomédico

Mérida, , Mexico

Instituto Cardiovascular de Monclova

Monclova, , Mexico

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, , Mexico

IMED Internal Medicine Clin Trials

Monterrey, , Mexico

Unidad de Investigación Clínica En Medicina SC

Monterrey, , Mexico

Diabetes Total, S.A de C.V.

Pachuca, , Mexico

Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.

Pachuca, , Mexico

Cardioarritmias e Investigación S.C.

San Luis Potosí City, , Mexico

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosí City, , Mexico

INBIOMEDYC Toluca

Toluca, , Mexico

Centro de Alta Especialidad Dr. Rafael Lucio

Veracruz, , Mexico

Dr. Humberto Alvarez Lopez

Zapopan, , Mexico

Meander Medisch Centrum

Amersfoort, , Netherlands

OLVG locatie Oost

Amsterdam, , Netherlands

VU Medisch Centrum

Amsterdam, , Netherlands

Podlaski Osrodek Kardiologii Poradnia Prywatna

Bialystok, , Poland

Malopolskie Centrum Sercowo-Naczyniowe

Chrzanów, , Poland

Polsko-Amerykanskie Kliniki Serca

Dąbrowa Górnicza, , Poland

Gabinet Kardiologiczno-Internistyczny

Gdynia, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med.

Kielce, , Poland

Diamond Clinic

Krakow, , Poland

Szpital Specjalistyczny im. Jozefa Dietla w Krakowie

Krakow, , Poland

Zespol Przychodni Specjalistycznych DIAB-END-COR Sp. z o.o.

Krakow, , Poland

Prywatna Praktyka Lekarska MAZ-MEDICA Maciej R.Mazurkiewicz

Lodz, , Poland

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

Lódz, , Poland

Polsko-Amerykanskie Kliniki Serca

Nysa, , Poland

Pro Corde, Dom Medyczny

Opole, , Poland

Medicome Sp. z o.o.

Oświęcim, , Poland

Rodzinne Centrum Zdrowia

Otwock, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"

Płock, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB

Tarnobrzeg, , Poland

Centrum Medyczne doktorA

Warsaw, , Poland

Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

Warsaw, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej AURUM

Warsaw, , Poland

Centrum Kardiologiczne Pro Corde Sp. z o.o. Niepubliczny Zaklad Opieki Zdrowotnej

Wroclaw, , Poland

Wro Medica

Wroclaw, , Poland

City Clinical Hospital #6

Chelyabinsk, , Russia

Federal Budget Healthcare Institution Medici - sanitary unit of Ministry of internal affairs of Russ

Kemerovo, , Russia

Research Institute of Complex Cardiovascular Pathology

Kemerovo, , Russia

Krasnodar Regional Clinical Hospital #2

Krasnodar, , Russia

Moscow City State Budgetary Healthcare Institution City Clinical Hospital named after V.V. Veresayev

Moscow, , Russia

Russian Cardiology Research and Production Center

Moscow, , Russia

City Hospital 13

Nizhny Novgorod, , Russia

State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital No. 19

Novosibirsk, , Russia

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, , Russia

Municipal Budgetary Healthcare Institution City Emergency Hospital

Rostov-on-Don, , Russia

International Medical Center SOGAZ

Saint Petersburg, , Russia

North-West State Medical University n.a. I.I. Mechnikov

Saint Petersburg, , Russia

St Petersburg City Outpatient Clinic #109

Saint Petersburg, , Russia

Saratov State Medical University

Saratov, , Russia

State Healthcare Institution Regional Clinical Cardiologic Dispensary

Saratov, , Russia

City Hospital #4

Sochi, , Russia

Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch

Tomsk, , Russia

State Budgetary Healthcare Institution of Vladimir Region City Hospital No. 4

Vladimir, , Russia

Ural State Medical University

Yekaterinburg, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Hospital Centar Zvezdara

Belgrade, , Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

Clinical Hospital Centre Zemun

Belgrade, , Serbia

Euromedik

Belgrade, , Serbia

Institute of Cardiovascular Diseases Dedinje

Belgrade, , Serbia

KBC Dr Dragisa Misovic Dedinje

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Institute Niska Banja

Niška Banja, , Serbia

Clinical Centre of Vojvodina

Novi Sad, , Serbia

General Hospital Uzice

Užice, , Serbia

Health Center Zajecar

Zaječar, , Serbia

ALIAN, s.r.o

Bardejov, , Slovakia

CARDIOCONSULT, s.r.o.

Bratislava, , Slovakia

Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

Kardio-Onkologia, s.r.o.

Dolný Kubín, , Slovakia

CARDIO D&R, s.r.o. Kosice

Košice, , Slovakia

Zeleznicne zdravotnictvo Kosice, s.r.o.

Košice, , Slovakia

KARDIOMED s.r.o.

Lučenec, , Slovakia

MEDI M&M s.r.o.

Moldava nad Bodvou, , Slovakia

Nemocnica s poliklinikou Nove Mesto nad Vahom n.o.

Nové Mesto nad Váhom, , Slovakia

Cardioinvest s. r. o.

Nové Zámky, , Slovakia

DIAB s.r.o.

Rožňava, , Slovakia

MEDIVASA, s.r.o.

Žilina, , Slovakia

Changhua Christian Hospital

Changhua, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Mackay Memorial Hospital-Taipei branch

New Taipei City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Cathay General Hospital

Taipei, , Taiwan

Chi Mei Medical Center

Taipei, , Taiwan

Far Eastern Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation Linkou Branch (Clinical Research Center)

Taoyuan, , Taiwan

Countries

Argentina; Australia; Belgium; Bulgaria; Croatia; Germany; Hungary; Israel; Mexico; Netherlands; Poland; Russia; Serbia; Slovakia; Taiwan

References

Ray KK, Nicholls SJ, Buhr KA, Ginsberg HN, Johansson JO, Kalantar-Zadeh K, Kulikowski E, Toth PP, Wong N, Sweeney M, Schwartz GG; BETonMACE Investigators and Committees. Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Apr 28;323(16):1565-1573. doi: 10.1001/jama.2020.3308.

Reference Type: RESULT

PMID: 32219359 (View on PubMed)

Schwartz GG, Nicholls SJ, Toth PP, Sweeney M, Halliday C, Johansson JO, Wong NCW, Kulikowski E, Kalantar-Zadeh K, Ginsberg HN, Ray KK. Relation of insulin treatment for type 2 diabetes to the risk of major adverse cardiovascular events after acute coronary syndrome: an analysis of the BETonMACE randomized clinical trial. Cardiovasc Diabetol. 2021 Jun 22;20(1):125. doi: 10.1186/s12933-021-01311-9.

Reference Type: DERIVED

PMID: 34158057 (View on PubMed)

Haarhaus M, Gilham D, Kulikowski E, Magnusson P, Kalantar-Zadeh K. Pharmacologic epigenetic modulators of alkaline phosphatase in chronic kidney disease. Curr Opin Nephrol Hypertens. 2020 Jan;29(1):4-15. doi: 10.1097/MNH.0000000000000570.

Reference Type: DERIVED

PMID: 31725015 (View on PubMed)

Ray KK, Nicholls SJ, Ginsberg HD, Johansson JO, Kalantar-Zadeh K, Kulikowski E, Toth PP, Wong N, Cummings JL, Sweeney M, Schwartz GG. Effect of selective BET protein inhibitor apabetalone on cardiovascular outcomes in patients with acute coronary syndrome and diabetes: Rationale, design, and baseline characteristics of the BETonMACE trial. Am Heart J. 2019 Nov;217:72-83. doi: 10.1016/j.ahj.2019.08.001. Epub 2019 Aug 9.

Reference Type: DERIVED

PMID: 31520897 (View on PubMed)

Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14.

Reference Type: DERIVED

PMID: 30476723 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RVX222-CS-015

Identifier Type: -

Identifier Source: org_study_id