Expired Study
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Durham, North Carolina 07969


Purpose:

Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.


Criteria:

Inclusion Criteria - Male or nonpregnant female greater than or equal to 18 years old - Ischemic pain originating or persisting at rest, or its clinical equivalent, lasting greater than or equal to 10 minutes and occurring within the 24 hours before enrollment - At least 2 of the following: - ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (greater than or equal to 1 mm), or transient (<30 minutes) ST-segment elevation greater than or equal to 0.1 mV (greater than or equal to 1 mm) in at least 2 contiguous leads - Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin I or T greater than the established criteria at each site OR creatine kinase CK-MB level greater than the site's upper limit of normal - Age greater than or equal to 60 years Exclusion Criteria: - Known or suspected pregnancy - Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding - Impaired hemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/mL), or history of thrombocytopenia with GP IIb/IIIa inhibitor therapy, heparin, or enoxaparin - Angina from a secondary cause such as severe, uncontrolled hypertension (systolic blood pressure >180 mm Hg despite treatment); anemia; valvular disease; congenital heart disease; hypertrophic cardiomyopathy; restrictive or constrictive cardiomyopathy; thyrotoxicosis - PCI within the past 24 hours, not including coronary angiography only - Allergy to pork or pork products - Contraindications to UFH or LMWH - Recent (<48 hours) or planned spinal/epidural anesthesia or puncture - Thrombolytic therapy within the preceding 24 hours - Other serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min - Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial - Inability to give informed consent or high likelihood of being unavailable for follow-up - Not a candidate for intervention, (angiography or PCI) - Treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.


NCT ID:

NCT00043784


Primary Contact:

Study Director
Doug Green
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 07969
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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