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

Phase 2

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT02387450
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-12
• Last Update Submitted: 2015-03-12
• Study First Posted: 2015-03-13
• Last Update Posted: 2015-03-13
• Study Start: 2015-09
• Primary Completion: 2017-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated group	Sildenafil	Sildenafil, oral, 100mg per day
Control group	Placebo	placebo oral

Primary Outcome Measures

Name	Time	Method
Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)	6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life Questionnaire	3, 6 and 9 months
Walking capacity (treadmill test)	3, 6 and 9 months	treadmill test
Proportion of revascularized patients	6 and 9 months	Revascularisation
Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)	3, 6 and 9 months	Proportion of Participants with Adverse Events (sildenafil vs. placebo)

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France