Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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).