CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Sanofi155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Thrombosis

Interventions

ClopidogrelDRUG

300 mg

ClopidogrelDRUG

600 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi aventis administrative office

México, Mexico

Outcomes

Primary Outcomes

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

Time frame: At 6 and 12 months post-PCI

Secondary Outcomes

Adverse events.

Time frame: From the beginning to the end of the study

Standard hematology and blood chemistry.

Time frame: At 6 and 12 months post-PCI

Data from ClinicalTrials.gov

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