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

Peripheral Arterial Disease Clinical Trial

Official title:

Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02387450
• Other study ID #: Ongoing recording
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 2, 2015
• Last updated: March 12, 2015
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2015
• Source: University Hospital, Angers
• Contact: pierre ABRAHAM, MD, PhD
• Phone: +33 241353689
• Email: piabraham[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Sildenafil
100 mg per day
• Placebo
Placebo with same presentation as the active drug

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)		6 months	Yes
Secondary	Quality of life Questionnaire		3, 6 and 9 months	No
Secondary	Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)	Proportion of Participants with Adverse Events (sildenafil vs. placebo)	3, 6 and 9 months	Yes
Secondary	Walking capacity (treadmill test)	treadmill test	3, 6 and 9 months	No
Secondary	Proportion of revascularized patients	Revascularisation	6 and 9 months	No