ISRCTN48678192进行中（未招募）3 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
niversity of Oxford (UK)0 个研究点目标入组 30,449 人开始时间: 2010年11月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30,449
研究概览
简要总结
2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28454801 design, recruitment, and baseline characteristics 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28847206 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31331193 results (added 25/07/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34910136/ longer-term follow-up results (added 01/02/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37750555/ Immediate- and longer-term impacts of new vascular and nonvascular events on QoL and hospital costs (added 27/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients must be aged at least 50 at the time of initial invitation
- •2. At least one of the following inclusion criteria must be satisfied:
- •2.1. History of Myocardial Infarction (MI)
- •2.2. Cerebrovascular atherosclerotic disease (i.e. history of presumed ischaemic stroke or carotid revascularization)
- •2.3. Peripheral arterial disease (i.e. history of non-coronary revascularization, including aortic aneurysm repair or graft)
- •2.4. 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)
排除标准
- •1. 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)
- •2. Planned coronary revascularization procedure within the next 6 months (such individuals may be entered later, if appropriate)
- •3. 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
- •4. Severe renal insufficiency (i.e. creatinine >200 µmol/L [2.3 mg/dL], dialysis or functioning renal transplant)
- •5. Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or CK >3x ULN
- •6. Previous significant adverse reaction to a statin or anacetrapib
- •7. Current treatment with any of the following lipid-lowering treatments:
- •7.1. 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
- •7.2. Fibric acid derivative ('fibrate', including gemfibrozil)
- •7.3. Niacin (nicotinic acid) at doses above 100 mg daily
- •8. Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin:
- •8.1. Any potent CYP3A4 inhibitor, such as:
- •8.1.1. Macrolide antibiotics (erythromycin, clarithromycin, telithromycin)
- •8.1.2. Daptomycin
- •8.1.3. Systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole)
- •8.1.4. Protease inhibitors (e.g. atazanavir)
- •8.1.5. Nefazodone
- •8.2. Ciclosporin
- •8.3. Systemic use of fusidic acid
- •9. Known to be poorly compliant with clinic visits or prescribed medication
- •10. 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)
- •11. Women of child-bearing potential (unless using adequate contraception)
- •12. Current participation in a clinical trial with an unlicensed drug or device
- •13. 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).
- •14. In addition, individuals will be excluded at the Randomization visit if any of the following are true:
- •14.1. Total cholesterol above 4 mmol/L [155 mg/dL]
- •14.2. Non-compliant with run-in treatment (<90% scheduled run-in medication taken)
- •14.3. Individual is no longer willing to be randomized into the 4-5 year trial
- •14.4. The individual?s doctor is of the view that their patient should not be randomized
研究者
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