CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Phase 3

Completed

• Conditions: Thrombosis
• Interventions: Drug: Clopidogrel

• Registration Number: NCT00716924
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2006-02
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-24
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Clopidogrel	600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
3	Clopidogrel	600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
1	Clopidogrel	300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI

Primary Outcome Measures

Name	Time	Method
Incidence of post-percutaneous coronary intervention elevation of troponin T.	At 6 and 12 months post-PCI

Secondary Outcome Measures

Name	Time	Method
Adverse events.	From the beginning to the end of the study
Standard hematology and blood chemistry.	At 6 and 12 months post-PCI

Trial Locations

Locations (1)

Sanofi aventis administrative office; 🇲🇽 Mexico, Mexico