Secondary Prevention of Cardiovascular Disease in the Elderly Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,499
- 试验地点
- 113
- 主要终点
- Major Cardiovascular Adverse Events (MACE)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.
详细描述
A total number of 2499 patients have been randomized (1:1) to treatment arms. Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic).
Patients will be ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment.
Once the inclusion and exclusion criteria are confirmed, patients will be included in the study after signing informed consent.
Randomization will take place within 6 months of the index event (AMI type I) in a 1:1 ratio to one of the two arms:
- Cardiovascular Polypill (containing Aspirin, Ramipril, and Atorvastatin)
- Usual care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with a type 1 myocardial infarction within the previous 6 months.
- •Subjects must be ≥65 years old, presenting with at least one of the following additional conditions:
- •Documented diabetes mellitus or previous treatment with oral hypoglycemic drugs or insulin.
- •Mild to moderate renal dysfunction: creatinine clearance 60-30 mL/min/1.73 m
- •Prior myocardial infarction: defined as an AMI occurring before the index event documented in a medical report.
- •Prior coronary revascularization: coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
- •Prior stroke: history of a documented stroke, defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, not resulting in death.
- •Age ≥ 75 years.
- •Signing informed consent.
排除标准
- •Unable to sign informed consent.
- •Contraindications to any of the components of the polypill.
- •Living in a nursing home.
- •Mental illness limiting the capacity of self-care.
- •Participating in another clinical trial.
- •Severe congestive heart failure (NYHA III-IV).
- •Severe renal disease (Creatinine Clearance (CrCl) <30ml/min/1.73 m2).
- •Need for oral anticoagulation at the time of randomization or planned in the future months.
- •Any condition limiting life expectancy <2 years, including but not limited to active malignancy.
- •Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation).
- •Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the prespecified timeframe).
- •Do not agree to the filing, forwarding and use of his/ her pseudonymised data.
研究组 & 干预措施
Treatment Prevention for Secondary CV
Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..
干预措施: Treatment Prevention for Secondary CV (Drug)
Cardiovascular Polypill
Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.
干预措施: Cardiovascular Polypill (Drug)
结局指标
主要结局
Major Cardiovascular Adverse Events (MACE)
时间窗: Up to 5 years
The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death.
次要结局
- Efficacy Endpoints(24 months)
- Safety Endpoints(Up to 5 Years)