search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2, Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apabetalone
Placebo
Atorvastatin
Rosuvastatin
Sponsored by
Resverlogix Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Investigaciones Clinicas Bahia Blanca
  • Bioclinica Buenos Aires
  • Centro Privado de Enfermedades Cardiovasculares
  • Consultorios Asociados Endocronología E Investigación Clínica Aplicada
  • Instituto Cardiovascular de Buenos Aires
  • Sanatorio Guemes
  • Clinica Coronel Suarez
  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral
  • CEMAIC
  • Centro Médico Colón
  • Centro Médico Luquez
  • Clínica Privada Del Prado Sociedad de Responsabilidad Limitada
  • Fundación Clínica Colombo
  • Hospital Cordoba
  • Hospital San Roque
  • Instituto Del Corazón
  • Instituto Modelo de Cardiologia
  • Instituto Médico DAMIC
  • Ipac Caraffa
  • Sanatorio Allende
  • Centro Médico Libertad
  • CIMEL
  • Instituto de Investigaciones Clínicas Mar Del Plata
  • Hospital Central
  • DIM Clinica Privada
  • Instituto de Hematologia Y Medicina Clinica
  • Sanatorio Britanico de Rosario
  • Prevencion Cardio Vascular
  • Grupo Medico Alem
  • Bioclinica Tucumán
  • Centro Modelo de Cardiologia
  • Investigaciones Clinicas Tucuman
  • Centro de Investigaciones Clínicas Del Litoral SRL
  • Sanatorio San Francisco
  • Clínica FUSAVIM Privada
  • Instituto de Investigaciones Clínicas Zárate
  • Flinders Medical Centre
  • ZNA Middelheim
  • Imelda VZW
  • AZ Turnhout
  • Multiprofile Hospital For Active Treatment Dr Tota Venkova
  • Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD
  • Multiprofile Hospital For Active Treatment - Pazardzhik AD
  • University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
  • City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Medical Center Kardiohelp EOOD
  • Second Multiprofile Hospital for Active Treatment Sofia
  • Synexus Affiliate - Diagnostic and Consulting Center Ascendent
  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
  • Medical Center Orfey OOD
  • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • General Hospital Karlovac
  • Special Hospital for medicinal rehabilitation Krapinske Toplice
  • Clinical Hospital Osijek
  • General Hospital Dr Josip Bencevic
  • General Hospital Virovitica
  • Clinical Hospital Sveti duh
  • DRK Kliniken Berlin Westend
  • Medizinisches Versorgungszentrum am Küchwald GmbH
  • Zentrum für Klinische Prüfung in der Facharztzentrum Dresden Neustadt Gbr
  • Katholisches Krankenhaus St. Johann Nepomuk
  • Heidelberger Praxisklinik für Kardiologie
  • Klinikum Hoyerswerda
  • Studienzentrum Dr.Appel
  • Asklepios Klinik Langen
  • Klinikum Leverkusen GmbH
  • Bajai Szent Rókus Kórház
  • Grof Tisza Istvan Korhaz Berettyoujfalu
  • Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet
  • Magyar Honvédség Egészségügyi Központ
  • Semmelweis Egyetem
  • Synexus (DRS) - Synexus Magyarország Kft. Budapest
  • Szent Margit Korhaz
  • Szent Rókus Kórház és Intézményei
  • Selye János Kórház
  • TaNaMed Kft.
  • Kanizsai Dorottya Kórház
  • Coromed-SMO Kft.
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Tolna Megyei Balassa János Kórház
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Barzilai Medical Center
  • Soroka University Medical Centre
  • Hillel Yaffe Medical Center
  • Bnei Zion Medical Center
  • Lady Davis Carmel Medical Center
  • Linn Medical Center Clalit Health Services
  • Rambam Medical Center
  • Edith Wolfson Medical Center
  • Hadassah University Hospital Ein Kerem
  • Hadassah University Hospital Mount Scopus
  • Shaare Zedek Medical Center
  • Meir Medical Center
  • Galilee Medical Center
  • Nazareth EMMS Hospital
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • ZIV Medical Center
  • Clalit Health Medical Center
  • Tel Aviv Sourasky Medical Center
  • Baruch Padeh Poriya Medical Center
  • Fundacion Cardiovascular de Aguascalientes AC
  • Hospital Cardiológica Aguascalientes
  • Investigacion en Salud y Metabolismo S.C.
  • Centro de Investigación Biomedica y Farmaceutica
  • Clinica Integral del Paciente Diabetico y Obeso
  • Fundación de Atención e Investigación Médica Lindavista S.C.
  • Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
  • Centro de Investigacion y Atencion de Diabetes, Endocrinologia y Nutricion
  • Arechavaleta Granell Maria del Rosario
  • Centro de Investigacion Medica Biologica Y de Terapia Avanzada SC
  • Unidad de Investigacion Clinica Cardiometabolica de Occidente SC
  • Hospital Angeles Leon
  • Centro de Desarrollo Biomédico
  • Sanatorio y Servicios Médicos Obregón S.A. de C.V.
  • Instituto Cardiovascular de Monclova
  • Hospital Universitario Dr. Jose Eleuterio González
  • IMED Internal Medicine Clin Trials
  • Unidad de Investigación Clínica En Medicina SC
  • Diabetes Total, S.A de C.V.
  • Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.
  • Cardioarritmias e Investigación S.C.
  • Hospital Central Dr Ignacio Morones Prieto
  • INBIOMEDYC Toluca
  • Centro de Alta Especialidad Dr. Rafael Lucio
  • Dr. Humberto Alvarez Lopez
  • Meander Medisch Centrum
  • OLVG locatie Oost
  • VU Medisch Centrum
  • Podlaski Osrodek Kardiologii Poradnia Prywatna
  • Malopolskie Centrum Sercowo-Naczyniowe
  • Polsko-Amerykanskie Kliniki Serca
  • Gabinet Kardiologiczno-Internistyczny
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med.
  • Diamond Clinic
  • Szpital Specjalistyczny im. Jozefa Dietla w Krakowie
  • Zespol Przychodni Specjalistycznych DIAB-END-COR Sp. z o.o.
  • Prywatna Praktyka Lekarska MAZ-MEDICA Maciej R.Mazurkiewicz
  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
  • Polsko-Amerykanskie Kliniki Serca
  • Pro Corde, Dom Medyczny
  • Medicome Sp. z o.o.
  • Rodzinne Centrum Zdrowia
  • Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB
  • Centrum Medyczne doktorA
  • Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
  • Niepubliczny Zaklad Opieki Zdrowotnej AURUM
  • Centrum Kardiologiczne Pro Corde Sp. z o.o. Niepubliczny Zaklad Opieki Zdrowotnej
  • Wro Medica
  • City Clinical Hospital #6
  • Ural State Medical University
  • Federal Budget Healthcare Institution Medici - sanitary unit of Ministry of internal affairs of Russ
  • Research Institute of Complex Cardiovascular Pathology
  • Krasnodar Regional Clinical Hospital #2
  • Moscow City State Budgetary Healthcare Institution City Clinical Hospital named after V.V. Veresayev
  • Russian Cardiology Research and Production Center
  • City Hospital 13
  • State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital No. 19
  • Republican Hospital n.a. V.A. Baranov
  • Municipal Budgetary Healthcare Institution City Emergency Hospital
  • International Medical Center SOGAZ
  • North-West State Medical University n.a. I.I. Mechnikov
  • St Petersburg City Outpatient Clinic #109
  • Saratov State Medical University
  • State Healthcare Institution Regional Clinical Cardiologic Dispensary
  • City Hospital #4
  • Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch
  • State Budgetary Healthcare Institution of Vladimir Region City Hospital No. 4
  • Clinical Center of Serbia
  • Clinical Hospital Centar Zvezdara
  • Clinical Hospital Center Bezanijska Kosa
  • Clinical Hospital Centre Zemun
  • Euromedik
  • Institute of Cardiovascular Diseases Dedinje
  • KBC Dr Dragisa Misovic Dedinje
  • Military Medical Academy
  • Clinical Center Kragujevac
  • Institute Niska Banja
  • Clinical Center Nis
  • Clinical Centre of Vojvodina
  • Institute of Cardiovascular Diseases of Vojvodina
  • General Hospital Uzice
  • Health Center Zajecar
  • ALIAN, s.r.o
  • CARDIOCONSULT, s.r.o.
  • Univerzitna nemocnica Bratislava
  • Kardio-Onkologia, s.r.o.
  • CARDIO D&R, s.r.o. Kosice
  • Zeleznicne zdravotnictvo Kosice, s.r.o.
  • KARDIOMED s.r.o.
  • MEDI M&M s.r.o.
  • Nemocnica s poliklinikou Nove Mesto nad Vahom n.o.
  • Cardioinvest s. r. o.
  • DIAB s.r.o.
  • MEDIVASA, s.r.o.
  • Changhua Christian Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung Veterans General Hospital
  • Mackay Memorial Hospital-Taipei branch
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • Tri-Service General Hospital
  • Cathay General Hospital
  • Chi Mei Medical Center
  • Far Eastern Memorial Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation Linkou Branch (Clinical Research Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Intensity statin therapy+RVX000222

High-Intensity statin therapy+Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2015
Last Updated
July 23, 2021
Sponsor
Resverlogix Corp
Collaborators
PPD, ICON plc, Medidata Solutions
search

1. Study Identification

Unique Protocol Identification Number
NCT02586155
Brief Title
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Resverlogix Corp
Collaborators
PPD, ICON plc, Medidata Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Intensity statin therapy+RVX000222
Arm Type
Experimental
Arm Description
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Arm Title
High-Intensity statin therapy+Placebo
Arm Type
Active Comparator
Arm Description
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Intervention Type
Drug
Intervention Name(s)
Apabetalone
Other Intervention Name(s)
RVX000222
Intervention Description
100 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for RVX000222)
Intervention Description
Capsule manufactured to mimic RVX000222 100 mg capsule
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
High-Intensity Statin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
High-Intensity Statin
Primary Outcome Measure Information:
Title
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Description
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.
Time Frame
120 weeks
Secondary Outcome Measure Information:
Title
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Description
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.
Time Frame
120 weeks
Title
Incidence of Hospitalization for Congestive Heart Failure (CHF)
Time Frame
120 weeks
Title
Incidence of All-cause Mortality
Time Frame
120 weeks
Title
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Time Frame
120 weeks
Title
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Time Frame
120 weeks
Title
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Time Frame
172 weeks
Title
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Time Frame
52 weeks
Title
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Time Frame
120 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32219359
Citation
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.
Results Reference
result
PubMed Identifier
34158057
Citation
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.
Results Reference
derived
PubMed Identifier
31725015
Citation
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.
Results Reference
derived
PubMed Identifier
31520897
Citation
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.
Results Reference
derived
PubMed Identifier
30476723
Citation
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.
Results Reference
derived
Links:
URL
https://jamanetwork.com/journals/jama/fullarticle/2763951
Description
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs