VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Experimental design A Phase III, National, Multicentre, Prospective, Randomised, Double Blind, placebo-controlled clinical trial with two parallel groups.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The preparation of the 'blinded' treatments will be undertaken by the PPRIGO hospital pharmacist's consortium (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest) under recommended standardised conditions. PPRIGO will provide numbered and labelled boxes each containing 33 capsules of the study drug (sildenafil or placebo) according to the randomisation order). All boxes will be identically labelled, with the study number being the only differentiating feature between different drug packs. The un-blinding will be centralised with eCRF software in agreement with the principal investigator.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Experimental design A National, Multicentre, Prospective, Randomised, Double Blind, placebo-controlled clinical trial with two parallel groups. Eligible patients will be randomised in two groups: Experimental group Sildenafil citrate 140 mg/day (single morning oral dose of 140 mg) for a total durati...
Experimental design A National, Multicentre, Prospective, Randomised, Double Blind, placebo-controlled clinical trial with two parallel groups. Eligible patients will be randomised in two groups: Experimental group Sildenafil citrate 140 mg/day (single morning oral dose of 140 mg) for a total duration of 24 weeks. Control group Placebo (single morning oral dose) for a total duration of 24 weeks. Treatment will be proposed in addition to optimal treatment (Antiplatelet + Lipid Lowering Drugs + AT2 antagonists / ACE Inhibitors; unless contra-indicated) + advice to walk. The experimental drug will be delivered for a 4 weeks treatment period. Phone contact will be carried out at 7 and 14 days focusing on tolerance, compliance and eventual side effects. First follow up visit at week 4 will focus on tolerance, compliance and side effects. If no major side effect is found, the study drug will be delivered for an additional 8 weeks. Phone contact will be carried out at 8 weeks focusing on tolerance, compliance and eventual side effects. Patients will be evaluated at week 12 (second follow-up visit) for persistent or non-persistent indication for revascularization and considered for revascularization if needed. In parallel, attention will be given to tolerance, compliance and eventual side effects. If no major side effect is found, the study drug will be delivered for an additional 12 weeks period. Phone contact will be carried out at weeks 16 and 20 focusing on tolerance, compliance and eventual side effects. Third and fourth follow-up visits are scheduled at week 24 (end of treatment) and week 48 (24 weeks after the end of experimental drugs). Perspectives Improving quality of life of patients suffering a chronic debilitating disease is a major issue not only in vascular medicine. It is expected that the treatment may help patients change from a vicious circle (Pain > inactivity > disease progression > pain > increased morbi-mortality) to a virtuous circle (no Pain > improved ability for activity > collateral vessel development > slowing of disease progression > decreased morbi-mortality ) We expect that half of the patients that fulfil inclusion criteria will be sufficiently improved not to require surgery anymore even 24 weeks after the end of the drug as a result of this virtuous circle.
Tracking Information
- NCT #
- NCT03686306
- Collaborators
- Not Provided
- Investigators
- Not Provided
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