CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Thrombosis

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716924

L_9317

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

2

Experimental group

Description:

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

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel

3

Experimental group

Description:

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

Treatment:

Drug: Clopidogrel

Drug: Clopidogrel