CASTLE (Clopidogrel And Serum Troponin Level Elevation)

NCT00716924 | Completed Phase 3

• 1 other identifier: L_9317
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

• Incidence of post-percutaneous coronary intervention elevation of troponin T.

  At 6 and 12 months post-PCI

Secondary Outcomes (2)

• Adverse events.

  From the beginning to the end of the study

• Standard hematology and blood chemistry.

  At 6 and 12 months post-PCI

Study Arms (3)

1

EXPERIMENTAL

300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI

Drug: Clopidogrel

2

EXPERIMENTAL

600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.

Drug: Clopidogrel

3

EXPERIMENTAL

600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

300 mg

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi aventis administrative office

México, Mexico

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Judith Diaz, Md

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: May 1, 2004
• Primary Completion: February 1, 2006
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

ME (1)