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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
400
100 mg per day
Placebo with same presentation as the active drug
Centre hospitalier universitaire
Angers, France
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)
Time frame: 6 months
Quality of life Questionnaire
Time frame: 3, 6 and 9 months
Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)
Proportion of Participants with Adverse Events (sildenafil vs. placebo)
Time frame: 3, 6 and 9 months
Walking capacity (treadmill test)
treadmill test
Time frame: 3, 6 and 9 months
Proportion of revascularized patients
Revascularisation
Time frame: 6 and 9 months
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