CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Study Overview
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Brief Summary
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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.

Official Title
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Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI | Drug: Clopidogrel<br>* 300 mg<br>|
| Experimental: 2<br>600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI. | Drug: Clopidogrel<br>* 600 mg<br>|
| Experimental: 3<br>600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI. | Drug: Clopidogrel<br>* 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-percutaneous coronary intervention elevation of troponin T. |  | At 6 and 12 months post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events. |  | From the beginning to the end of the study | 
| Standard hematology and blood chemistry. |  | At 6 and 12 months post-PCI |