MT1002 Phase II Study in ACS Patients With PCI

Exclusion Criteria

• •1. .Cardiogenic shock or prolonged cardiopulmonary resuscitation (CPR).
• •2. Active bleeding, bleeding diathesis, coagulopathy.
• •3. Any history of intracranial bleeding or structural abnormalities.
• •4. Prior transient ischemic attack, prior stroke within 6 months.
• •5. Index MI is STEMI or new left bundle branch block.
• •6. The following planned procedures within 30 days after enrollment: staged PCI, CABG, valve surgery, or additional invasive procedures.
• •7. Pre-existing atrial fibrillation or prolonged QTcF (470ms in men, 480ms in women).
• •8. Anticipated requirement for oral anticoagulants before Day 30.
• •9. CRUSADE bleeding risk score \>40.
• •10. Suspected aortic dissection.
• •11. History of gastrointestinal or genitourinary bleeding within the previous 3 months.
• •12. Refusal to receive blood transfusion if needed during the study.
• •13. Major surgery in the last month.
• •14. History of heparin-induced thrombocytopenia and bleeding diathesis.
• •15. Severe uncontrolled hypertension.
• •16. Prior (within 30 days prior to enrollment) or planned administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, bivalirudin, or fondaparinux for the index MI.
• •17. Known relevant hematological deviations: hemoglobin (male) \< 11 g/dL, hemoglobin (female) \< 10 g/dL, hematocrit \< 35%, platelet count \< 100,000 cells/µL.
• •18. Use of Coumadin derivatives and/or Factor Xa inhibitor drugs within the last 7 days.
• •19. Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs; except aspirin) , cyclooxygenase (COX)-2 inhibitors within 1 month before screening.
• •20. Known malignancies or other comorbid conditions with life expectancy \< 1 year.
• •21. Known severe liver disease (i.e., aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] \> 3 × ULN).
• •22. Known positive serology for hepatitis B \& C, HIV screen.
• •23. Known chronic kidney disease with estimated glomerular filtration rate (eGFR) \<30 mL/min and/or dialysis.
• •24. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast.