Peripheral Arterial Disease Clinical Trial
Official title:
Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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