CASTLE (Clopidogrel And Serum Troponin Level Elevation)

NCT ID: NCT00716924

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31

Brief Summary

Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

300 mg

2

600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

600 mg

3

600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

600 mg

Interventions

Clopidogrel

300 mg

Intervention Type: DRUG

Clopidogrel

600 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
• Patients undergoing stent implantation

Exclusion Criteria

• Any known contraindication to the use of aspirin or clopidogrel.
• Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
• Elective administration of IIb/IIIa inhibitors.
• Cardiogenic shock
• Acute MI< 24 hours
• BP systolic <100 mmHg
• Left ventricular ejection fraction < 30%
• Heart failure, NYHA class III or IV
• Severe renal insufficiency (creatinine > 3.0 mg/dL)
• Platelet count <100,000/mm³
• Target lesion in a venous bypass graft
• Target lesion in a chronic occlusion

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Judith Diaz, Md

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi aventis administrative office

México, , Mexico

Countries

Mexico

Other Identifiers

L_9317

Identifier Type: -

Identifier Source: org_study_id