Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174759
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-09-09
Brief Title:
CASPAR Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Double-blind Randomized Study of Clopidogrel 75 mgd vs Placebo on a Background of ASA 75-100 mgdin 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 od versus placebo on a background of ASA 75-100 mgd 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 od versus placebo on a background of ASA 75-100 mgd 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2004-000822-58 | None | None | None |