Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02387450|
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Angers.
Recruitment status was: Not yet recruiting
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: Sildenafil Drug: Placebo||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||September 2017|
Active Comparator: Treated group
Sildenafil, oral, 100mg per day
100 mg per day
Other Name: Viagra or revatio
Placebo Comparator: Control group
Placebo with same presentation as the active drug
- Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) [ Time Frame: 6 months ]
- Quality of life Questionnaire [ Time Frame: 3, 6 and 9 months ]
- Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event) [ Time Frame: 3, 6 and 9 months ]Proportion of Participants with Adverse Events (sildenafil vs. placebo)
- Walking capacity (treadmill test) [ Time Frame: 3, 6 and 9 months ]treadmill test
- Proportion of revascularized patients [ Time Frame: 6 and 9 months ]Revascularisation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387450
|Contact: pierre ABRAHAM, MD, PhD||+33 email@example.com|
|Centre hospitalier universitaire|
|Angers, France, 49933|
|Principal Investigator:||pierre Abraham, MD, PhD||University Hospital in Angers|