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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02586155




Registration number
NCT02586155
Ethics application status
Date submitted
21/10/2015
Date registered
26/10/2015
Date last updated
20/08/2021

Titles & IDs
Public title
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
Scientific 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)
Secondary ID [1] 0 0
RVX222-CS-015
Universal Trial Number (UTN)
Trial acronym
BETonMACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apabetalone
Treatment: Drugs - Placebo
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Rosuvastatin

Experimental: High-Intensity statin therapy+RVX000222 - Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)

Active comparator: High-Intensity statin therapy+Placebo - Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)


Treatment: Drugs: Apabetalone
100 mg capsule

Treatment: Drugs: Placebo
Capsule manufactured to mimic RVX000222 100 mg capsule

Treatment: Drugs: Atorvastatin
High-Intensity Statin

Treatment: Drugs: Rosuvastatin
High-Intensity Statin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Timepoint [1] 0 0
120 weeks
Secondary outcome [1] 0 0
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Timepoint [1] 0 0
120 weeks
Secondary outcome [2] 0 0
Incidence of Hospitalization for Congestive Heart Failure (CHF)
Timepoint [2] 0 0
120 weeks
Secondary outcome [3] 0 0
Incidence of All-cause Mortality
Timepoint [3] 0 0
120 weeks
Secondary outcome [4] 0 0
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [4] 0 0
120 weeks
Secondary outcome [5] 0 0
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [5] 0 0
120 weeks
Secondary outcome [6] 0 0
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [6] 0 0
120 weeks
Secondary outcome [7] 0 0
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [7] 0 0
120 weeks
Secondary outcome [8] 0 0
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [8] 0 0
120 weeks
Secondary outcome [9] 0 0
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Timepoint [9] 0 0
120 weeks
Secondary outcome [10] 0 0
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Timepoint [10] 0 0
120 weeks
Secondary outcome [11] 0 0
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Timepoint [11] 0 0
172 weeks
Secondary outcome [12] 0 0
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Timepoint [12] 0 0
52 weeks
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
120 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2021
Sample size
Target
Accrual to date
Final
2425
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Bahía Blanca
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Argentina
State/province [2] 0 0
Buenos Aires
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Argentina
State/province [3] 0 0
Coronel Suárez
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Argentina
State/province [4] 0 0
Corrientes
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Argentina
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Córdoba
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Argentina
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Haedo
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Argentina
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Lanús
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Argentina
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Mar Del Plata
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Argentina
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Mendoza
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Argentina
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Ramos Mejia
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Rosario
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Salta
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San Isidro
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San Miguel De Tucumán
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Santa Fe
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Santiago Del Estero
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Villa María
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Zárate
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Belgium
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Antwerpen
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Belgium
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Bonheiden
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Belgium
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Turnhout
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Bulgaria
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Gabrovo
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Lovech
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Pazardzhik
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Bulgaria
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Pleven
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Smolyan
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Varna
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Karlovac
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Krapinske Toplice
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Croatia
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Osijek
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Zagreb
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Heidelberg
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Germany
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Hoyerswerda
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Germany
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Kassel
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Germany
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Langen
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Germany
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Leverkusen
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Hungary
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Baja
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Hungary
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Berettyóújfalu
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Komárom
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Szeged
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Székesfehérvár
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Ashkelon
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Holon
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Kefar-Sava
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Amsterdam
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Opole
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Oswiecim
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Otwock
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Plock
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Poland
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Tarnobrzeg
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Moscow
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Nizhniy Novgorod
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Russian Federation
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Russian Federation
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Petrozavodsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Sochi
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Russian Federation
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Tomsk
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Russian Federation
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Vladimir
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Niska Banja
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Serbia
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Nis
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Serbia
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Novi Sad
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Serbia
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Sremska Kamenica
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Serbia
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Uzice
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Serbia
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Zajecar
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Dolny Kubin
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Slovakia
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Kosice
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Slovakia
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Lucenec
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State/province [133] 0 0
Moldava nad Bodvou
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Nove Mesto nad Vahom
Country [135] 0 0
Slovakia
State/province [135] 0 0
Nove Zamky
Country [136] 0 0
Slovakia
State/province [136] 0 0
Roznava
Country [137] 0 0
Slovakia
State/province [137] 0 0
Zilina
Country [138] 0 0
Taiwan
State/province [138] 0 0
Changhua
Country [139] 0 0
Taiwan
State/province [139] 0 0
Kaohsiung
Country [140] 0 0
Taiwan
State/province [140] 0 0
New Taipei City
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taichung
Country [142] 0 0
Taiwan
State/province [142] 0 0
Tainan City
Country [143] 0 0
Taiwan
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Taipei City
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taipei
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Resverlogix Corp
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
ICON plc
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Medidata Solutions
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02586155
Trial related presentations / publications
Ray KK, Nicholls SJ, Buhr KA, Ginsberg HN, Johansson JO, Kalantar-Zadeh K, Kulikowski E, Toth PP, Wong N, Sweeney M, Schwartz GG; BETonMACE Investigators and Committees. Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Apr 28;323(16):1565-1573. doi: 10.1001/jama.2020.3308.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Kausik Ray, MD
Address 0 0
Imperial College London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02586155