Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.

Official Title

Multi-arm Optimization of Stroke Thrombolysis (MOST): a Blinded, Randomized Controlled Adaptive, Multi-arm, Adjunctive-thrombolysis Efficacy Trial in Ischemic Stroke

Keywords

Acute Ischemic StrokeStrokeIschemiaEptifibatideArgatroban

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Acute ischemic stroke patients
  2. Treated with 0.9mg/kg IV rt-PA within 3 hours of stroke onset or time last known well
  3. Age ≥ 18
  4. NIHSS score ≥ 6 prior to IV rt-PA
  5. Able to receive assigned study drug within 60 minutes of initiation of IV rt-PA

You CAN'T join if...

  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. 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 >180mmHg post-IV rt-PA
  9. Diastolic blood pressure >105mmHg post-IV rt-PA
  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 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 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, eptifibatide or argatroban therapy was initiated
  25. Example: known cirrhosis or clinically significant hepatic disease
  26. . Current participation in another research drug treatment protocol - Subjects could not start another experimental agent until after 90 days
  27. . Informed consent from the patient or the legally authorized representative was not or could not be obtained
  28. . High density lesion consistent with hemorrhage of any degree
  29. . 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

Locations

  • UCSD Health La Jollanot yet accepting patients
    La JollaCalifornia92037United States
  • UCSD Medical Center - Hillcrest Hospitalnot yet accepting patients
    San DiegoCalifornia92103United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Cincinnati
ID
NCT03735979
Phase
Phase 3
Study Type
Interventional
Last Updated