NCT00317707已完成3 期
Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 12,513 人开始时间: 2004年2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
- 已完成
- 发起方
- 入组人数
- 12,513
- 试验地点
- 1
- 主要终点
- cardiovascular deaths and hospitalization for cardiovascular causes
研究概览
简要总结
In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.
Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.
The Risk and Prevention study combines an epidemiological and an experimental approach in order to:
- Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)
- Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of cardiovascular events, through a controlled, randomised, double blind clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Multiple risk factors:
- •diabetes,
- •age => 65 years,
- •male sex,
- •hypertension,
- •hypercholesterolemia,
- •family history of premature cardiovascular disease;
- •Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack [TIA], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)
排除标准
- •Contraindications (known allergies to n-3 PUFA) or indications (previous myocardial infarction) for the treatment with n-3 PUFA
- •Serious comorbidity with an unfavourable prognosis over the short term
- •Expected non compliance over a long period of time
- •Pregnancy
研究组 & 干预措施
N-3 PUFA
Experimental
干预措施: N-3 Polyunsaturated Fatty Acids (Drug)
结局指标
主要结局
cardiovascular deaths and hospitalization for cardiovascular causes
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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