Multi-arm Optimization of Stroke Thrombolysis

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Nov 7, 2018

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Eligibility criteria

• Inclusion Criteria:
• • 1. Acute ischemic stroke patients
• • 2. Treated with 0.9mg/kg IV rt-PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well
• • 3. Age ≥ 18
• • 4. NIHSS score ≥ 6 prior to IV thrombolysis
• • 5. Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis
• Exclusion Criteria:
• • 1. Known allergy or hypersensitivity to argatroban or eptifibatide
• • 2. Previous stroke in the past 90 days
• • 3. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
• • 4. Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
• • 5. Any surgery, or biopsy of parenchymal organ in the past 30 days
• • 6. Trauma with internal injuries or ulcerative wounds in the past 30 days
• • 7. Severe head trauma in the past 90 days
• • 8. Systolic blood pressure persistently \>180mmHg post-IV thrombolysis despite antihypertensive intervention
• • 9. Diastolic blood pressure persistently \>105mmHg post-IV thrombolysis despite antihypertensive intervention
• • 10. Serious systemic hemorrhage in the past 30 days
• • 11. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.5
• • 12. Positive urine or serum pregnancy test for women of child bearing potential
• • 13. Glucose \<50 or \>400 mg/dl
• • 14. Platelets \<100,000/mm3
• • 15. Hematocrit \<25 %
• • 16. Elevated pre-thrombolysis PTT above laboratory upper limit of normal
• • 17. Creatinine \> 4 mg/dl
• • 18. Ongoing renal dialysis, regardless of creatinine
• • 19. Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
• • 20. Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
• • 21. Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours
• • 22. Received glycoprotein IIb/IIIa inhibitors within the past 14 days
• • 23. Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score \>3
• • 24. Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if rt-PA, TNK, eptifibatide or argatroban therapy was initiated
• • a. Example: known cirrhosis or clinically significant hepatic disease
• • 25. Current participation in another research drug treatment or interventional device trial - Subjects could not start another experimental agent until after 90 days
• • 26. Informed consent from the patient or the legally authorized representative was not or could not be obtained
• • 27. High density lesion consistent with hemorrhage of any degree
• • 28. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT Scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment