Status:
ACTIVE_NOT_RECRUITING
REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL) trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the risk of coronary...
Detailed Description
Sub-study: Does anacetrapib as a CETP inhibitor lead to mobilization of stem cells and enhance myocardial function via neoangiogenesis and tissue regeneration? Following the main on-treatment part of...
Eligibility Criteria
Inclusion
- Patients must be aged at least 50 at the time of initial invitation, and at least one of the following inclusion criteria must be satisfied:
- History of MI; or
- Cerebrovascular atherosclerotic disease (i.e. history of presumed ischaemic stroke or carotid revascularization); or
- Peripheral arterial disease (i.e. history of non-coronary revascularization, including aortic aneurysm repair or graft); or
- Diabetes mellitus with other evidence of symptomatic coronary heart disease (i.e. treatment or hospitalization for angina, or a history of coronary revascularization or acute coronary syndrome).
Exclusion
- None of the following must be satisfied:
- Acute MI, acute coronary syndrome or stroke within 4 weeks prior to Screening Visit or during Run-in (but such individuals may be entered later, if appropriate);
- Planned coronary revascularization procedure within the next 6 months (such individuals may be entered later, if appropriate);
- Definite history of chronic liver disease, or abnormal liver function (i.e. alanine transaminase (ALT) \>2x the upper limit of normal (ULN)). Note: Individuals with a history of acute hepatitis are eligible provided this ALT limit is not exceeded;
- Severe renal insufficiency (i.e. creatinine \>200 µmol/L \[2.3 mg/dL\], dialysis or functioning renal transplant);
- Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) \>3x ULN;
- Previous significant adverse reaction to a statin or anacetrapib;
- Current treatment with any of the following lipid-lowering treatments:
- (i) a regimen considered to produce substantially greater LDL cholesterol reduction than atorvastatin 80 mg daily for individuals in non-Asian countries or 20 mg daily for those in North East Asia; or (ii) fibric acid derivative ("fibrate", including gemfibrozil); or (iii) niacin (nicotinic acid) at doses above 100 mg daily
- Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin:
- (i) any potent CYP3A4 inhibitor, such as:
- macrolide antibiotics (erythromycin, clarithromycin, telithromycin);
- systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole);
- protease inhibitors (e.g. atazanavir);
- nefazodone
- (ii) ciclosporin
- (iii) daptomycin
- (iv) systemic use of fusidic acid
- Note: Individuals who are taking such drugs temporarily may be re-screened when they discontinue them, if considered appropriate;
- Known to be poorly compliant with clinic visits or prescribed medication;
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 5 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse);
- Women of child-bearing potential (unless using adequate contraception);
- Current participation in a clinical trial with an unlicensed drug or device.
- Individuals will also be excluded at the Screening visit if it is considered unlikely that they will achieve total cholesterol \<3.5 mmol/L (135 mg/dL) on the highest atorvastatin dose available in their region (atorvastatin 80 mg daily in non-Asian countries or 20 mg daily in North East Asia).
- In addition, individuals will be excluded at the Randomization visit if any of the following are true:
- Total cholesterol above 4 mmol/L \[155 mg/dL\]
- Non-compliant with run-in treatment (\<90% scheduled run-in medication taken)
- Individual is no longer willing to be randomized into the 4-5 year trial
- The individual's doctor is of the view that their patient should not be randomized.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2037
Estimated Enrollment :
30449 Patients enrolled
Trial Details
Trial ID
NCT01252953
Start Date
June 1 2011
End Date
January 31 2037
Last Update
June 25 2024
Active Locations (1)
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1
CTSU, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7LF