CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Thrombosis Clinical Trial

— CASTLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716924
• Other study ID #: L_9317
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2008
• Last updated: September 24, 2009
• Start date: May 2004

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Clopidogrel
300 mg
• Clopidogrel
600 mg

Locations

Country	Name	City	State
Mexico	Sanofi aventis administrative office	Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-percutaneous coronary intervention elevation of troponin T.		At 6 and 12 months post-PCI	No
Secondary	Adverse events.		From the beginning to the end of the study	No
Secondary	Standard hematology and blood chemistry.		At 6 and 12 months post-PCI	No