Peripheral Arterial Occlusive Disease Clinical Trial
— VALSTAROfficial title:
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication. A National, Multicentre, Prospective, Randomised, Double-Blind, Placebo-Controlled Trial.
NCT number | NCT02930811 |
Other study ID # | PHRC-N-2015 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated |
Verified date | November 2018 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million
people around the world and about 7 million people in France. Morbi-mortality from
cardiovascular events is increased in this population. Intermittent claudication is the most
common clinical feature of PAD.
Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type
5, is well tolerated, largely used in impotence and has interesting clinical delay and
duration of action in the concept of a potential use in claudication.
For patients agreeing and signing informed consent, randomisation of treatment
(placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment.
The experimental drug will be delivered for a 1 month treatment. First follow up visit at
month one will focus on tolerance, compliance and eventual side effects. If no major side
effect is found the study drug will then be delivered for an additional 2 months. Patients
will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent
indication for revascularisation and addressed for revascularization if needed. In parallel
focus on tolerance, compliance and eventual side effects will be done. If no major side
effect is found, the study drug will be delivered for an additional 3 months treatment. Third
and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months
after the end of experimental drugs).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Grade I cat 2 or 3 claudication despite optimal medical treatment - Reporting a vascular claudication history for at least 3 months - Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes - Having no cons Sildenafil indication - Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month Exclusion Criteria: - Critical ischemia - Previous history of myocardial infarction or angina not stabilized - Amblyopia - Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil - Pregnant woman and woman in labor - Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research - Being in an exclusion period for another biomedical study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of Event free survival rate | Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up | 6 months after the treatment begining |
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