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CASTLE (Clopidogrel And Serum Troponin Level Elevation)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00716924
First received: July 15, 2008
Last updated: September 24, 2009
Last verified: September 2009
History of Changes

July 15, 2008
September 24, 2009
May 2004
February 2006   (final data collection date for primary outcome measure)
Incidence of post-percutaneous coronary intervention elevation of troponin T. [ Time Frame: At 6 and 12 months post-PCI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00716924 on ClinicalTrials.gov Archive Site
  • Adverse events. [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Standard hematology and blood chemistry. [ Time Frame: At 6 and 12 months post-PCI ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CASTLE (Clopidogrel And Serum Troponin Level Elevation)
Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombosis
  • Drug: Clopidogrel
    300 mg
  • Drug: Clopidogrel
    600 mg
  • Experimental: 1
    300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI
    Intervention: Drug: Clopidogrel
  • Experimental: 2
    600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
    Intervention: Drug: Clopidogrel
  • Experimental: 3
    600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
Not Provided
February 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00716924
L_9317
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Bristol-Myers Squibb
Study Director: Judith Diaz, Md Sanofi
Sanofi
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP