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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00174759 |
Purpose
Primary objective:
To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.
Secondary objectives:
Comparison, between the two treatment groups, of :
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Diseases |
Drug: Clopidogrel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft. |
| Estimated Enrollment: | 1460 |
| Study Start Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: A patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled:
Exclusion criteria :
PAD medical/surgical history
Medical history related to bleeding risk
Other medical conditions
Contacts and Locations| Australia | |
| Sanofi-aventis | |
| North Ryde, Australia | |
| Austria | |
| Sanofi-aventis | |
| Vienna, Austria | |
| Belgium | |
| Sanofi-aventis | |
| Brussels, Belgium | |
| Finland | |
| Sanofi-aventis | |
| Helsinki, Finland | |
| France | |
| Sanofi-aventis | |
| Paris, France | |
| Germany | |
| Sanofi-aventis | |
| Berlin, Germany | |
| Hungary | |
| Sanofi-aventis | |
| Budapest, Hungary | |
| Italy | |
| Sanofi-aventis | |
| Milan, Italy | |
| Netherlands | |
| Sanofi-aventis | |
| Gouda, Netherlands | |
| Poland | |
| Sanofi-aventis | |
| Warsaw, Poland | |
| Spain | |
| Sanofi-aventis | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-aventis | |
| Stockholm, Sweden | |
| Switzerland | |
| Sanofi-aventis | |
| Meyrin, Switzerland | |
| United Kingdom | |
| Sanofi-aventis | |
| Guildford, United Kingdom | |
| Study Director: | Luc Sagnard | Sanofi-Aventis |
More Information
| Study ID Numbers: | C-9253, EudraCT #: 2004-000822-58 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00174759 History of Changes |
| Health Authority: | Scotland: Scottish Executive Health Department |
|
Arterial Occlusive Diseases Peripheral Vascular Diseases Therapeutic Uses Clopidogrel Hematologic Agents |
Vascular Diseases Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |