EUCTR2010-023467-18-FI进行中（未招募）1 期
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 - REVEA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30,449
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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 noncoronary
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15000
排除标准
- •None of the following must be satisfied:
- •Acute MI, acute coronary syndrome or stroke within 4 weeks prior to Screening Visit or during Runin (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 rescreened 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 nonmelanoma skin cancer; or recent history of alcohol or substance misuse);
- •Women of childbearing 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
- •Noncompliant with run-in treatment (<90% scheduled run-in medication taken)
- •Individual is no longer willing to be randomized into the 45 year trial
- •The individual’s doctor is of the view that their patient should not be randomized.
研究者
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