Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 standard of
care thrombolysis (0.9mg/kg IV rt-PA or 0.25mg/kg IV tenecteplase or TNK) 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.
Phase
Phase 3
Funding Agency/Sponsor
Other
Disease
Stroke
Enrollment Eligibility
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