Clinical Assessment of Pidogrel® Versus Plavix® (CAPP) | NCT01431495

Studies
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

NCT01431495

Sponsor

Les Laboratoires des Médicaments Stériles

Status

Completed

Last Update Posted

Sep 9, 2011Estimated

Enrollment

219Actual

Phase

Phase 4

Conditions

Coronary Disease

Interventions

Pidogrel
Plavix

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 25, 2011

First Submission Date that Met QC Criteria

Sep 8, 2011

First Posted Date

Sep 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2011

Last Update Posted Date

Sep 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

219Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
plavix	Active Comparator	patient treated by the princeps	Drug: Plavix
Pidogrel	Active Comparator	patient treated by Pidogrel	Drug: Pidogrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pidogrel	Drug	Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.	Pidogrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)		06 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female,
Old (e) over 20 years
Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)
Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)

Exclusion Criteria:

Patients unwilling.
Patient participating in another study.
Patients with cardiogenic shock
Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
Patients scheduled for surgery in less than 6 months.
Patients candidates for coronary angioplasty
Patients who underwent TAC + / - bare stent fewer than 30 days.
Patients who underwent stenting with ATC active there is less than 12 months.
ischemic stroke older than 6 weeks.
History of hemorrhagic stroke (any time)
Patients on warfarin or candidates
Patients with a different anti ADP (ticlopidine, prasugrel)
Patients with indication for clopidogrel-cons (side effects, bleeding ...)
Thrombocytopenia <100000/mm3
anemia (Ht <30%)
Thrombocythaemia (Ht> 52%)
Patients seeking treatment for an elective forms of Clopidogrel.
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003327	Coronary Disease
D002318	Cardiovascular Diseases

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds