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

Coronary Artery Disease Clinical Trial

— BETonMACE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586155
• Other study ID #: RVX222-CS-015
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2021
• Source: Resverlogix Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2425
• Est. completion date: June 21, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Drug:
• Apabetalone
100 mg capsule
• Placebo
Capsule manufactured to mimic RVX000222 100 mg capsule
• Atorvastatin
High-Intensity Statin
• Rosuvastatin
High-Intensity Statin

Locations

Country	Name	City	State
Argentina	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	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 Médico DAMIC	Córdoba
Argentina	Instituto Modelo de Cardiologia	Córdoba
Argentina	Ipac Caraffa	Córdoba
Argentina	Sanatorio Allende	Córdoba
Argentina	Clinica Coronel Suarez	Coronel Suárez
Argentina	Instituto de Cardiologia de Corrientes Juana Francisca Cabral	Corrientes
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 Mejia
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
Australia	Flinders Medical Centre	Bedford Park
Belgium	ZNA Middelheim	Antwerpen
Belgium	Imelda VZW	Bonheiden
Belgium	AZ Turnhout	Turnhout
Bulgaria	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
Croatia	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
Germany	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
Hungary	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	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Hungary	Tolna Megyei Balassa János Kórház	Szekszárd
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Centre	Be'er Sheva
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
Mexico	Fundacion Cardiovascular de Aguascalientes AC	Aguascalientes
Mexico	Hospital Cardiológica Aguascalientes	Aguascalientes
Mexico	Investigacion en Salud y Metabolismo S.C.	Chihuahua
Mexico	Centro de Investigación Biomedica y Farmaceutica	Ciudad de México
Mexico	Clinica Integral del Paciente Diabetico y Obeso	Ciudad De México
Mexico	Fundación de Atención e Investigación Médica Lindavista S.C.	Ciudad de México
Mexico	Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC	Culiacan
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 De Los Aldama
Mexico	Centro de Desarrollo Biomédico	Merida
Mexico	Sanatorio y Servicios Médicos Obregón S.A. de C.V.	Mexico City
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 Potosi
Mexico	Hospital Central Dr Ignacio Morones Prieto	San Luis Potosí
Mexico	INBIOMEDYC Toluca	Toluca
Mexico	Centro de Alta Especialidad Dr. Rafael Lucio	Veracruz
Mexico	Dr. Humberto Alvarez Lopez	Zapopan
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	OLVG locatie Oost	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Poland	Podlaski Osrodek Kardiologii Poradnia Prywatna	Bialystok
Poland	Malopolskie Centrum Sercowo-Naczyniowe	Chrzanow
Poland	Polsko-Amerykanskie Kliniki Serca	Dabrowa Gornicza
Poland	Gabinet Kardiologiczno-Internistyczny	Gdynia
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med.	Kielce
Poland	Diamond Clinic	Kraków
Poland	Szpital Specjalistyczny im. Jozefa Dietla w Krakowie	Kraków
Poland	Zespol Przychodni Specjalistycznych DIAB-END-COR Sp. z o.o.	Kraków
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.	Oswiecim
Poland	Rodzinne Centrum Zdrowia	Otwock
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"	Plock
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB	Tarnobrzeg
Poland	Centrum Medyczne doktorA	Warszawa
Poland	Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej AURUM	Warszawa
Poland	Centrum Kardiologiczne Pro Corde Sp. z o.o. Niepubliczny Zaklad Opieki Zdrowotnej	Wroclaw
Poland	Wro Medica	Wroclaw
Russian Federation	City Clinical Hospital #6	Chelyabinsk
Russian Federation	Ural State Medical University	Ekaterinburg
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	Kemerovo
Russian Federation	Krasnodar Regional Clinical Hospital #2	Krasnodar
Russian Federation	Moscow City State Budgetary Healthcare Institution City Clinical Hospital named after V.V. Veresayev	Moscow
Russian Federation	Russian Cardiology Research and Production Center	Moscow
Russian Federation	City Hospital 13	Nizhniy Novgorod
Russian Federation	State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital No. 19	Novosibirsk
Russian Federation	Republican Hospital n.a. V.A. Baranov	Petrozavodsk
Russian Federation	Municipal Budgetary Healthcare Institution City Emergency Hospital	Rostov-on-Don
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	Saint Petersburg
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	State Healthcare Institution Regional Clinical Cardiologic Dispensary	Saratov
Russian Federation	City Hospital #4	Sochi
Russian Federation	Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch	Tomsk
Russian Federation	State Budgetary Healthcare Institution of Vladimir Region City Hospital No. 4	Vladimir
Serbia	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	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	Nis
Serbia	Institute Niska Banja	Niska Banja
Serbia	Clinical Centre of Vojvodina	Novi Sad
Serbia	Institute of Cardiovascular Diseases of Vojvodina	Sremska Kamenica
Serbia	General Hospital Uzice	Uzice
Serbia	Health Center Zajecar	Zajecar
Slovakia	ALIAN, s.r.o	Bardejov
Slovakia	CARDIOCONSULT, s.r.o.	Bratislava
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	Kardio-Onkologia, s.r.o.	Dolny Kubin
Slovakia	CARDIO D&R, s.r.o. Kosice	Kosice
Slovakia	Zeleznicne zdravotnictvo Kosice, s.r.o.	Kosice
Slovakia	KARDIOMED s.r.o.	Lucenec
Slovakia	MEDI M&M s.r.o.	Moldava nad Bodvou
Slovakia	Nemocnica s poliklinikou Nove Mesto nad Vahom n.o.	Nove Mesto nad Vahom
Slovakia	Cardioinvest s. r. o.	Nove Zamky
Slovakia	DIAB s.r.o.	Roznava
Slovakia	MEDIVASA, s.r.o.	Zilina
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
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 City
Taiwan	Chang Gung Medical Foundation Linkou Branch (Clinical Research Center)	Taoyuan City

Sponsors (4)

Lead Sponsor	Collaborator
Resverlogix Corp	ICON plc, Medidata Solutions, PPD

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Bulgaria,  Croatia,  Germany,  Hungary,  Israel,  Mexico,  Netherlands,  Poland,  Russian Federation,  Serbia,  Slovakia,  Taiwan, 

References & Publications (1)

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 Event — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	120 weeks
Secondary	Incidence of Hospitalization for Congestive Heart Failure (CHF)		120 weeks
Secondary	Incidence of All-cause Mortality		120 weeks
Secondary	Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups		120 weeks
Secondary	Change in Glucose From Baseline Over Time Between and Within Treatment Groups		120 weeks
Secondary	Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups		172 weeks
Secondary	Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups		52 weeks
Secondary	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)		120 weeks

External Links

•   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