CASTLE (Clopidogrel And Serum Troponin Level Elevation) - Full Text View

Sponsors and Collaborators:	Sanofi-Aventis Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00716924

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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
1: Experimental 300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI	Drug: Clopidogrel 300 mg
2: Experimental 600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.	Drug: Clopidogrel 600 mg
3: Experimental 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-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

Judith Diaz, Md

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_9317
Study First Received:	July 15, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00716924 History of Changes
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Clopidogrel

Vascular Diseases
Platelet Aggregation Inhibitors
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Therapeutic Uses
Clopidogrel
Hematologic Agents
Vascular Diseases

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Thrombosis

ClinicalTrials.gov processed this record on September 10, 2009