Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis In Myocardial Infarction
ExTRACT Trial
General Information
Study Information
Inclusion & Exclusion Criteria
Patients with STEMI meeting all of the following criteria will be eligible for enrollment:
1. Male or non-pregnant female ≥18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years).
2. Onset of prolonged (≥20 min) ischemic symptoms at rest ≤6 hours prior to randomization.
3. ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in 2 or more contiguous precordial leads, or left bundle branch block.
4. Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase.
5. Written informed consent will be obtained.
EXCLUSION CRITERIA
Patients presenting with any of the following will not be included in the study:
Cardiovascular
1. Evidence of cardiogenic shock at randomization.
2. Acute pericarditis.
3. History or symptoms suggestive of aortic dissection.
4. Myocardial infarction precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine.
Hemorrhagic risk
5. Any minor head trauma or any other trauma occurring after the index AMI.
6. Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.
7. Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia.
8. Any single reliable recording of systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg prior to randomization.
9. Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease
10. Any known structural damage or other pathologic process involving the central nervous system (CNS).
11. Any head trauma within 6 months prior to randomization.
12. Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization.
13. Traumatic or prolonged cardiopulmonary resuscitation (> 2 min) within 2 weeks prior to randomization.
14. Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization.
15. Acute peptic ulcer disease within 3 months prior to randomization.
Prior or concomitant pharmacologic therapy
16. Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide.
(Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization.
17. Current therapy with oral anticoagulants, or a known International Normalized Ratio (INR) of > 1.5.
18. Administration of a LMWH within 8 hours prior to randomization.
19. Known hypersensitivity to LMWHs, UFH or heparin-like products; allergy to pork or pork products.
20. Known hypersensitivity or contraindication(s) to fibrinolytic drugs (streptokinase,
tenecteplase, alteplase, and reteplase).
General
21. Known platelet count < 100,000/L or history of heparin-induced thrombocytopenia.
22. Known clinically significant anemia (hemoglobin < 10 g/dL which is < 6.2 mmol/L)
23. Known renal insufficiency with serum creatinine > 220 mol/L (2.5 mg/dL) for men and > 175 mol/L (2.0 mg/dL) for women when assessed prior to baseline examination.
24. Advanced neoplastic or other life-threatening disease with a life expectancy of < 12 months.
25. Pregnancy or parturition within the last 90 days or currently breast feeding.
26. Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control, or having a negative pregnancy test.
27. Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25.
28. History of drug or alcohol abuse.
29. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
30. 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.
Patients with STEMI meeting all of the following criteria will be eligible for enrollment:
1. Male or non-pregnant female ≥18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years).
2. Onset of prolonged (≥20 min) ischemic symptoms at rest ≤6 hours prior to randomization.
3. ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in 2 or more contiguous precordial leads, or left bundle branch block.
4. Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase.
5. Written informed consent will be obtained.
EXCLUSION CRITERIA
Patients presenting with any of the following will not be included in the study:
Cardiovascular
1. Evidence of cardiogenic shock at randomization.
2. Acute pericarditis.
3. History or symptoms suggestive of aortic dissection.
4. Myocardial infarction precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine.
Hemorrhagic risk
5. Any minor head trauma or any other trauma occurring after the index AMI.
6. Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.
7. Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia.
8. Any single reliable recording of systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg prior to randomization.
9. Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease
10. Any known structural damage or other pathologic process involving the central nervous system (CNS).
11. Any head trauma within 6 months prior to randomization.
12. Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization.
13. Traumatic or prolonged cardiopulmonary resuscitation (> 2 min) within 2 weeks prior to randomization.
14. Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization.
15. Acute peptic ulcer disease within 3 months prior to randomization.
Prior or concomitant pharmacologic therapy
16. Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide.
(Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization.
17. Current therapy with oral anticoagulants, or a known International Normalized Ratio (INR) of > 1.5.
18. Administration of a LMWH within 8 hours prior to randomization.
19. Known hypersensitivity to LMWHs, UFH or heparin-like products; allergy to pork or pork products.
20. Known hypersensitivity or contraindication(s) to fibrinolytic drugs (streptokinase,
tenecteplase, alteplase, and reteplase).
General
21. Known platelet count < 100,000/L or history of heparin-induced thrombocytopenia.
22. Known clinically significant anemia (hemoglobin < 10 g/dL which is < 6.2 mmol/L)
23. Known renal insufficiency with serum creatinine > 220 mol/L (2.5 mg/dL) for men and > 175 mol/L (2.0 mg/dL) for women when assessed prior to baseline examination.
24. Advanced neoplastic or other life-threatening disease with a life expectancy of < 12 months.
25. Pregnancy or parturition within the last 90 days or currently breast feeding.
26. Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control, or having a negative pregnancy test.
27. Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25.
28. History of drug or alcohol abuse.
29. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
30. 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.
Study Timeline