Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
BETonMACE
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)
1 other identifier
interventional
2,425
15 countries
214
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Nov 2015
Longer than P75 for phase_3 diabetes-mellitus-type-2
214 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2021
CompletedResults Posted
Study results publicly available
August 20, 2021
CompletedAugust 20, 2021
July 1, 2021
5.1 years
October 21, 2015
June 21, 2021
July 23, 2021
Conditions
Outcome Measures
Primary Outcomes (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.
120 weeks
Secondary Outcomes (13)
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
120 weeks
Incidence of Hospitalization for Congestive Heart Failure (CHF)
120 weeks
Incidence of All-cause Mortality
120 weeks
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
120 weeks
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
120 weeks
- +8 more secondary outcomes
Study Arms (2)
High-Intensity statin therapy+RVX000222
EXPERIMENTALDaily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
High-Intensity statin therapy+Placebo
ACTIVE COMPARATORPlacebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Interventions
Capsule manufactured to mimic RVX000222 100 mg capsule
High-Intensity Statin
High-Intensity Statin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resverlogix Corplead
- PPD Development, LPcollaborator
- ICON plccollaborator
- Medidata Solutionscollaborator
Study Sites (214)
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, 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
Related Publications (5)
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.
PMID: 32219359RESULTSchwartz 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.
PMID: 34158057DERIVEDHaarhaus 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.
PMID: 31725015DERIVEDRay 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.
PMID: 31520897DERIVEDGilham 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.
PMID: 30476723DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director of Clinical Operations
- Organization
- Resverlogix Corp.
Study Officials
- STUDY CHAIR
Kausik Ray, MD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 26, 2015
Study Start
November 1, 2015
Primary Completion
November 30, 2020
Study Completion
June 21, 2021
Last Updated
August 20, 2021
Results First Posted
August 20, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share