AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3BETonMACENCT02586155

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

A Phase 3 study testing Apabetalone, Atorvastatin and Rosuvastatin in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Resverlogix Corp at 214 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apabetalone, Atorvastatin and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,425 participants
Where
214 sitesin 15 countries
Study dates
Nov 2015to 21 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

214 sites in 15 countries.

214 sites in 15 countries

Argentina36 sites

  • Instituto de Investigaciones Clinicas Bahia Blanca

    Bahía Blanca

  • Bioclinica Buenos Aires

    Buenos Aires

  • Centro Privado de Enfermedades Cardiovasculares

    Buenos Aires

  • Consultorios Asociados Endocronología E Investigación Clínica Aplicada

    Buenos Aires

  • Instituto Cardiovascular de Buenos Aires

    Buenos Aires

  • Sanatorio Guemes

    Buenos Aires

  • CEMAIC

    Córdoba

  • Centro Médico Colón

    Córdoba

  • Centro Médico Luquez

    Córdoba

  • Clínica Privada Del Prado Sociedad de Responsabilidad Limitada

    Córdoba

  • Fundación Clínica Colombo

    Córdoba

  • Hospital Cordoba

    Córdoba

  • Hospital San Roque

    Córdoba

  • Instituto Del Corazón

    Córdoba

  • Instituto Modelo de Cardiologia

    Córdoba

  • Instituto Médico DAMIC

    Córdoba

  • Ipac Caraffa

    Córdoba

  • Sanatorio Allende

    Córdoba

  • Clinica Coronel Suarez

    Coronel Suárez

  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral

    Corrientes

  • Centro Médico Libertad

    Haedo

  • CIMEL

    Lanus

  • Instituto de Investigaciones Clínicas Mar Del Plata

    Mar del Plata

  • Hospital Central

    Mendoza

  • DIM Clinica Privada

    Ramos Mejía

  • Instituto de Hematologia Y Medicina Clinica

    Rosario

  • Sanatorio Britanico de Rosario

    Rosario

  • Prevencion Cardio Vascular

    Salta

  • Grupo Medico Alem

    San Isidro

  • Bioclinica Tucumán

    San Miguel de Tucumán

  • Centro Modelo de Cardiologia

    San Miguel de Tucumán

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán

  • Centro de Investigaciones Clínicas Del Litoral SRL

    Santa Fe

  • Sanatorio San Francisco

    Santiago del Estero

  • Clínica FUSAVIM Privada

    Villa María

  • Instituto de Investigaciones Clínicas Zárate

    Zárate

Other trials in Argentina

Mexico25 sites

  • Fundacion Cardiovascular de Aguascalientes AC

    Aguascalientes

  • Hospital Cardiológica Aguascalientes

    Aguascalientes

  • Investigacion en Salud y Metabolismo S.C.

    Chihuahua City

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

    Culiacán

  • Centro de Investigacion y Atencion de Diabetes, Endocrinologia y Nutricion

    Durango

  • Arechavaleta Granell Maria del Rosario

    Guadalajara

  • Centro de Investigacion Medica Biologica Y de Terapia Avanzada SC

    Guadalajara

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente SC

    Guadalajara

  • Hospital Angeles Leon

    León

  • Centro de Desarrollo Biomédico

    Mérida

  • Centro de Investigación Biomedica y Farmaceutica

    Mexico City

  • Clinica Integral del Paciente Diabetico y Obeso

    Mexico City

  • Fundación de Atención e Investigación Médica Lindavista S.C.

    Mexico City

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

    Mexico City

  • Instituto Cardiovascular de Monclova

    Monclova

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey

  • IMED Internal Medicine Clin Trials

    Monterrey

  • Unidad de Investigación Clínica En Medicina SC

    Monterrey

  • Diabetes Total, S.A de C.V.

    Pachuca

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

    Pachuca

  • Cardioarritmias e Investigación S.C.

    San Luis Potosí City

  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosí City

  • INBIOMEDYC Toluca

    Toluca

  • Centro de Alta Especialidad Dr. Rafael Lucio

    Veracruz

  • Dr. Humberto Alvarez Lopez

    Zapopan

Other trials in Mexico

Poland21 sites

  • Podlaski Osrodek Kardiologii Poradnia Prywatna

    Bialystok

  • Malopolskie Centrum Sercowo-Naczyniowe

    Chrzanów

  • Polsko-Amerykanskie Kliniki Serca

    Dąbrowa Górnicza

  • Gabinet Kardiologiczno-Internistyczny

    Gdynia

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med.

    Kielce

  • Diamond Clinic

    Krakow

  • Szpital Specjalistyczny im. Jozefa Dietla w Krakowie

    Krakow

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

    Krakow

  • Prywatna Praktyka Lekarska MAZ-MEDICA Maciej R.Mazurkiewicz

    Lodz

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lódz

  • Polsko-Amerykanskie Kliniki Serca

    Nysa

  • Pro Corde, Dom Medyczny

    Opole

  • Medicome Sp. z o.o.

    Oświęcim

  • Rodzinne Centrum Zdrowia

    Otwock

  • Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"

    Płock

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB

    Tarnobrzeg

  • Centrum Medyczne doktorA

    Warsaw

  • Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

    Warsaw

  • Niepubliczny Zaklad Opieki Zdrowotnej AURUM

    Warsaw

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

    Wroclaw

  • Wro Medica

    Wroclaw

Other trials in Poland

Israel20 sites

  • Barzilai Medical Center

    Ashkelon

  • Soroka University Medical Centre

    Beersheba

  • Hillel Yaffe Medical Center

    Hadera

  • Bnei Zion Medical Center

    Haifa

  • Lady Davis Carmel Medical Center

    Haifa

  • Linn Medical Center Clalit Health Services

    Haifa

  • Rambam Medical Center

    Haifa

  • Edith Wolfson Medical Center

    Holon

  • Hadassah University Hospital Ein Kerem

    Jerusalem

  • Hadassah University Hospital Mount Scopus

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Meir Medical Center

    Kefar Sava

  • Galilee Medical Center

    Nahariya

  • Nazareth EMMS Hospital

    Nazareth

  • Chaim Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot

  • ZIV Medical Center

    Safed

  • Clalit Health Medical Center

    Tel Aviv

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • Baruch Padeh Poriya Medical Center

    Tiberias

Other trials in Israel

Russia19 sites

  • City Clinical Hospital #6

    Chelyabinsk

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

    Kemerovo

  • Research Institute of Complex Cardiovascular Pathology

    Kemerovo

  • Krasnodar Regional Clinical Hospital #2

    Krasnodar

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

    Moscow

  • Russian Cardiology Research and Production Center

    Moscow

  • City Hospital 13

    Nizhny Novgorod

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

    Novosibirsk

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk

  • Municipal Budgetary Healthcare Institution City Emergency Hospital

    Rostov-on-Don

  • International Medical Center SOGAZ

    Saint Petersburg

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

    Saint Petersburg

  • St Petersburg City Outpatient Clinic #109

    Saint Petersburg

  • Saratov State Medical University

    Saratov

  • State Healthcare Institution Regional Clinical Cardiologic Dispensary

    Saratov

  • City Hospital #4

    Sochi

  • Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch

    Tomsk

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

    Vladimir

  • Ural State Medical University

    Yekaterinburg

Other trials in Russia

Hungary17 sites

  • Bajai Szent Rókus Kórház

    Baja

  • Grof Tisza Istvan Korhaz Berettyoujfalu

    Berettyóújfalu

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest

  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

    Budapest

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet

    Budapest

  • Magyar Honvédség Egészségügyi Központ

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Synexus (DRS) - Synexus Magyarország Kft. Budapest

    Budapest

  • Szent Margit Korhaz

    Budapest

  • Szent Rókus Kórház és Intézményei

    Budapest

  • Selye János Kórház

    Komárom

  • TaNaMed Kft.

    Mosonmagyaróvár

  • Kanizsai Dorottya Kórház

    Nagykanizsa

  • Coromed-SMO Kft.

    Pécs

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

  • Tolna Megyei Balassa János Kórház

    Szekszárd

Other trials in Hungary

Serbia15 sites

  • Clinical Center of Serbia

    Belgrade

  • Clinical Hospital Centar Zvezdara

    Belgrade

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade

  • Clinical Hospital Centre Zemun

    Belgrade

  • Euromedik

    Belgrade

  • Institute of Cardiovascular Diseases Dedinje

    Belgrade

  • KBC Dr Dragisa Misovic Dedinje

    Belgrade

  • Military Medical Academy

    Belgrade

  • Institute of Cardiovascular Diseases of Vojvodina

    Kamenitz

  • Clinical Center Kragujevac

    Kragujevac

  • Clinical Center Nis

    Niš

  • Institute Niska Banja

    Niška Banja

  • Clinical Centre of Vojvodina

    Novi Sad

  • General Hospital Uzice

    Užice

  • Health Center Zajecar

    Zaječar

Other trials in Serbia

Bulgaria14 sites

  • Multiprofile Hospital For Active Treatment Dr Tota Venkova

    Gabrovo

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

    Lovech

  • Multiprofile Hospital For Active Treatment - Pazardzhik AD

    Pazardzhik

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

    Pleven

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

    Smolyan

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

    Sofia

  • City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia

  • Medical Center Kardiohelp EOOD

    Sofia

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia

  • Synexus Affiliate - Diagnostic and Consulting Center Ascendent

    Sofia

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia

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

    Sofia

  • Medical Center Orfey OOD

    Stara Zagora

  • Multiprofile Hospital for Active Treatment Sveta Marina EAD

    Varna

Other trials in Bulgaria

Taiwan13 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • Mackay Memorial Hospital-Taipei branch

    New Taipei City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Cathay General Hospital

    Taipei

  • Chi Mei Medical Center

    Taipei

  • Far Eastern Memorial Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang Gung Medical Foundation Linkou Branch (Clinical Research Center)

    Taoyuan City

Other trials in Taiwan

Slovakia12 sites

  • ALIAN, s.r.o

    Bardejov

  • CARDIOCONSULT, s.r.o.

    Bratislava

  • Univerzitna nemocnica Bratislava

    Bratislava

  • Kardio-Onkologia, s.r.o.

    Dolný Kubín

  • CARDIO D&R, s.r.o. Kosice

    Košice

  • Zeleznicne zdravotnictvo Kosice, s.r.o.

    Košice

  • KARDIOMED s.r.o.

    Lučenec

  • MEDI M&M s.r.o.

    Moldava nad Bodvou

  • Nemocnica s poliklinikou Nove Mesto nad Vahom n.o.

    Nové Mesto nad Váhom

  • Cardioinvest s. r. o.

    Nové Zámky

  • DIAB s.r.o.

    Rožňava

  • MEDIVASA, s.r.o.

    Žilina

Other trials in Slovakia

Germany9 sites

  • DRK Kliniken Berlin Westend

    Berlin

  • Medizinisches Versorgungszentrum am Küchwald GmbH

    Chemnitz

  • Zentrum für Klinische Prüfung in der Facharztzentrum Dresden Neustadt Gbr

    Dresden

  • Katholisches Krankenhaus St. Johann Nepomuk

    Erfurt

  • Heidelberger Praxisklinik für Kardiologie

    Heidelberg

  • Klinikum Hoyerswerda

    Hoyerswerda

  • Studienzentrum Dr.Appel

    Kassel

  • Asklepios Klinik Langen

    Langen

  • Klinikum Leverkusen GmbH

    Leverkusen

Other trials in Germany

Croatia6 sites

  • General Hospital Karlovac

    Karlovac

  • Special Hospital for medicinal rehabilitation Krapinske Toplice

    Krapinske Toplice

  • Clinical Hospital Osijek

    Osijek

  • General Hospital Dr Josip Bencevic

    Slavonski Brod

  • General Hospital Virovitica

    Virovitica

  • Clinical Hospital Sveti duh

    Zagreb

Other trials in Croatia

Belgium3 sites

  • ZNA Middelheim

    Antwerp

  • Imelda VZW

    Bonheiden

  • AZ Turnhout

    Turnhout

Other trials in Belgium

Netherlands3 sites

  • Meander Medisch Centrum

    Amersfoort

  • OLVG locatie Oost

    Amsterdam

  • VU Medisch Centrum

    Amsterdam

Other trials in Netherlands

Australia1 site

  • Flinders Medical Centre

    Bedford Park

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
Apabetalone, Placebo, Atorvastatin, Rosuvastatin
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApabetaloneDrug

    Also called RVX000222

    100 mg capsule

  • PlaceboDrug

    Also called Placebo (for RVX000222)

    Capsule manufactured to mimic RVX000222 100 mg capsule

  • AtorvastatinDrug

    Also called Lipitor

    High-Intensity Statin

  • RosuvastatinDrug

    Also called Crestor

    High-Intensity Statin

Study groups in NCT02586155
Study groupRoleWhat they receive
High-Intensity statin therapy+RVX000222ExperimentalDaily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Receives: Drug: Apabetalone; Drug: Atorvastatin; Drug: Rosuvastatin
High-Intensity statin therapy+PlaceboActive comparatorPlacebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Receives: Drug: Placebo; Drug: Atorvastatin; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE

    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.

    Measured: 120 weeks

Secondary outcomes (13)

  1. Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE

    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.

    Measured: 120 weeks

  2. Incidence of Hospitalization for Congestive Heart Failure (CHF)

    Measured: 120 weeks

  3. Incidence of All-cause Mortality

    Measured: 120 weeks

  4. Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  5. Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  6. Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  7. Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  8. Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  9. Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups

    Measured: 120 weeks

  10. Change in Glucose From Baseline Over Time Between and Within Treatment Groups

    Measured: 120 weeks

  11. Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups

    Measured: 172 weeks

  12. Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups

    Measured: 52 weeks

  13. 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)

    Measured: 120 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion30 Nov 2020
  4. Study completion21 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586155
Sponsor's protocol ID
RVX222-CS-015
Acronym
BETonMACE
Status last verified
Jul 2021
First submitted
21 Oct 2015
Last updated
20 Aug 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32219359

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apabetalone, Atorvastatin and Rosuvastatin in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Resverlogix Corp at 214 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in Argentina, Mexico, Poland, Israel, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE (time frame: 120 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586155, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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