REVEAL: Randomized EValuation of the Effects of Anacetrapib through Lipid-modification. A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease - REVEAL Version 1.0

• Conditions: Atherosclerotic cardiovascular disease; MedDRA version: 18.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866

• Registration Number: EUCTR2010-023467-18-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

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 hospitalisation for angina, or a history of coronary revascularization or acute coronary syndrome).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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. ALT >2x 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, dialysis or functioning renal transplant);
•Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or 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;
(ii) fibric acid derivative (fibrate, including gemfibrozil); or
(iii) niacin (nicotinic acid) at doses above 100mg daily;
•Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin:
(i)any potent CYP3A4 inhibitor, such as:
(a)macrolide antibiotics (erythromycin, clarithromycin, telithromycin);
(b)daptomycin
(c)systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole);
(d)protease inhibitors (e.g. atazanavir);
(e)nefazodone
(ii)ciclosporin
(iii)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 on the highest atorvastatin dose (80 mg daily).

In addition, individuals will be excluded at the Randomization visit if any of the following are true:
•Total cholesterol (on desktop analyser) above 4 mmol/L
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified