Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 5:29 PM
Study NCT ID:
NCT01431495
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2011-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
Sponsor:
Les Laboratoires des Médicaments Stériles
Organization:
Study Overview
Official Title:
Clinical Assessment of Pidogrel® Versus Plavix®
Status:
COMPLETED
Status Verified Date:
2011-09
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:
(CAPP)
Brief Summary:
This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:
* Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
* Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
* Safety Criteria: severe bleeding (GUSTO scale).
* Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
* Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
* Safety Criteria: severe bleeding (GUSTO scale).
Detailed Description:
after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU\> 235 or %inhibition \<15%.
Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU\> 235 or %inhibition \<15%.
Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
Study Oversight
Has Oversight DMC:
True
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?: