Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Acute ST-Segment Elevation

Myocardial Infarction

Treatments

Drug: Enoxaparin sodium (XRP4563)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00077792

XRP4563B/3001

EFC6147

Details and patient eligibility

About

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

Enrollment

20,506 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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