Multi-arm Optimization of Stroke Thrombolysis

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT03735979

Run by

Washington University School of Medicine

People needed

514

Starts

2019-10-15

Expected to finish

2024-10-31

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute ischemic stroke patients
• 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
• Age ≥ 18
• NIHSS score ≥ 6 prior to IV thrombolysis
• Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis

You may not qualify if…

• Known allergy or hypersensitivity to argatroban or eptifibatide
• Previous stroke in the past 90 days
• Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
• Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
• Any surgery, or biopsy of parenchymal organ in the past 30 days
• Trauma with internal injuries or ulcerative wounds in the past 30 days
• Severe head trauma in the past 90 days
• Systolic blood pressure persistently >180mmHg post-IV thrombolysis despite antihypertensive intervention
• Diastolic blood pressure persistently >105mmHg post-IV thrombolysis despite antihypertensive intervention
• Serious systemic hemorrhage in the past 30 days
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.5
• Positive urine or serum pregnancy test for women of child bearing potential
• Glucose <50 or >400 mg/dl
• Platelets <100,000/mm3
• Hematocrit <25 %
• Elevated pre-thrombolysis PTT above laboratory upper limit of normal
• Creatinine > 4 mg/dl
• Ongoing renal dialysis, regardless of creatinine
• Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
• Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
• Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours
• Received glycoprotein IIb/IIIa inhibitors within the past 14 days
• Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score >3
• 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

Where it is running

• St. Jude Medical Center — Fullerton, California, United States
• UCSD Health La Jolla — La Jolla, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Medical Center — Orange, California, United States
• UCSD Medical Center - Hillcrest Hospital — San Diego, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic Hospital — Jacksonville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Javon Bea Hospital - Riverside — Rockford, Illinois, United States
• Central DuPage Hospital — Winfield, Illinois, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Alabama Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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