NCT01187992终止3 期
Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease
San Filippo Neri General Hospital1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-ST-segment elevation acute myocardial infarction.
- •coronary angiography within 48 hours from admission.
- •angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).
排除标准
- •ST-segment elevation acute myocardial infarction,
- •clinical history of heart failure
- •left ventricular ejection fraction <35%,
- •any form of severe valvular dysfunction,
- •previous implantation or indication to implant a cardioverter-defibrillator during the index admission,
- •any increase in liver enzymes,
- •history of any liver or muscle disease,
- •renal failure with serum creatinine >2.5 mg/dL (221 mmol/L),
- •need for continued use of intravenous medications to relieve anginal symptoms,
- •presence of any major comorbidity with life expectancy <24 months.
研究组 & 干预措施
Full-dose atorovastatin (80 mg/d)
Experimental
For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Major adverse cardiovascular events
时间窗: 12 months
The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.
次要结局
- Cardiovascular mortality(12 months)
- Non-fatal acute myocardial re-infarction (re-AMI)(12 months)
- Disabling non-fatal stroke(12 months)
- New-onset heart failure(12 months)
- Atrial fibrillation(12 months)
研究者
研究点 (1)
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