Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-25 @ 9:39 PM
Study NCT ID:
NCT00174759
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Sponsor:
Sanofi
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 :
* Primary patency,
* Assisted primary patency,
* Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
* Ankle Brachial Pressure Index (ABPI) changes from baseline
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 :
* Primary patency,
* Assisted primary patency,
* Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
* Ankle Brachial Pressure Index (ABPI) changes from baseline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT #: 2004-000822-58 | None | None | View |