CASTLE (Clopidogrel And Serum Troponin Level Elevation)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Clopidogrel; Ticlopidine

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.