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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
  Purpose

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.


Condition Intervention Phase
Thrombosis
 Drug: Clopidogrel
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence of post-percutaneous coronary intervention elevation of troponin T. [ Time Frame: At 6 and 12 months post-PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 155
Study Start Date: May 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI
 Drug: Clopidogrel
300 mg
Experimental: 2
600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
 Drug: Clopidogrel
600 mg
Experimental: 3
600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
 Drug: Clopidogrel
600 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716924

Locations
Mexico
Sanofi aventis administrative office
Mexico, Mexico
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Judith Diaz, Md Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00716924     History of Changes
Other Study ID Numbers: L_9317
Study First Received: July 15, 2008
Last Updated: September 24, 2009
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013