Status:
COMPLETED
CASTLE (Clopidogrel And Serum Troponin Level Elevation)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00716924
Start Date
May 1 2004
Last Update
September 25 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi aventis administrative office
México, Mexico