Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

University Hospital, Angers

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Peripheral Arterial Disease

Treatments: Drug: Sildenafil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02387450

Ongoing recording

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Refuse to participate
• Administrative protection
• Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Treated group

Active Comparator group

Description:

Sildenafil, oral, 100mg per day

Treatment:

Drug: Sildenafil

Control group

Placebo Comparator group

Description:

placebo oral

Treatment:

Drug: Placebo