Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy


Criteria:

INCLUSION CRITERIA: Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria: - Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years) - Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization - ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block - Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase - Written informed consent will be obtained EXCLUSION CRITERIA: Cardiovascular - Evidence of cardiogenic shock at randomization - Acute pericarditis - History or symptoms suggestive of aortic dissection - MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine Hemorrhagic Risk - Any minor head trauma or any other trauma occurring after the index acute myocardial infarction - Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria. - Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia - Any single reliable recording of systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg prior to randomization - Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease - Any known structural damage or other pathologic process involving the central nervous system - Any head trauma within 6 months prior to randomization - Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization - Traumatic or prolonged cardiopulmonary resuscitation (> 2 minutes) within 2 weeks prior to randomization - Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization - Acute peptic ulcer disease within 3 months prior to randomization Prior or Concomitant Pharmacologic Therapy - Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization - Current therapy with oral anticoagulants, or an International Normalized Ratio of >1.5 - Administration of a low molecular weight heparin within 8 hours prior to randomization. - Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products - Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase) General - Known platelet count <100,000 cells/microL or history of heparin-induced thrombocytopenia - Known clinically significant anemia (Hemoglobin <10 g/dL which is < 6.2 mmol/L) - Known renal insufficiency with serum creatinine >220 mmol/L (2.5 mg/dL) for men and >175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination. - Advanced neoplastic or other life-threatening disease with a life expectancy of <12 months - Pregnancy or parturition within the last 90 days or currently breast feeding - Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test. - Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25 - History of drug or alcohol abuse - Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study - Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study


NCT ID:

NCT00077792


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
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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