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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Active Comparator | Sildenafil, oral, 100mg per day |
|
| Control group | Placebo Comparator | placebo oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | 100 mg per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life Questionnaire | 3, 6 and 9 months | |
| Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event) | Proportion of Participants with Adverse Events (sildenafil vs. placebo) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| pierre ABRAHAM, MD, PhD | Contact | +33 241353689 | piabraham@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| pierre Abraham, MD, PhD | University Hospital in Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire | Angers | 49933 | France |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | Placebo with same presentation as the active drug |
|
| 3, 6 and 9 months |
| Walking capacity (treadmill test) | treadmill test | 3, 6 and 9 months |
| Proportion of revascularized patients | Revascularisation | 6 and 9 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |