Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)
研究概览
简要总结
Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.
详细描述
Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.
Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.
Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ABI<0.90
- •Vascular type claudication
- •stable walking impairment for at least 3 months
- •Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
- •Age > 30 years
排除标准
- •Refuse to participate
- •Administrative protection
- •Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure
研究组 & 干预措施
Treated group
Sildenafil, oral, 100mg per day
干预措施: Sildenafil (Drug)
Control group
placebo oral
干预措施: Placebo (Drug)
结局指标
主要结局
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)
时间窗: 6 months
次要结局
- Quality of life Questionnaire(3, 6 and 9 months)
- Walking capacity (treadmill test)(3, 6 and 9 months)
- Proportion of revascularized patients(6 and 9 months)
- Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)(3, 6 and 9 months)