Blood Clot Treatments for Stroke

(MOST Trial)

Recruiting at 68 trial locations

Overseen By Andrew Barreto, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Must be taking: Thrombolytics

Must not be taking: Anticoagulants, Glycoprotein IIb/IIIa inhibitors

Disqualifiers: Pregnancy, Recent stroke, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 hours

514 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Opeolu Adeoye, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 with acute ischemic stroke who've received IV thrombolysis within 3 hours of symptom onset. They must have an NIHSS score ≥ 6 and be able to get the study drug within 60-75 minutes after starting thrombolysis. Exclusions include recent surgery, uncontrolled high blood pressure, severe kidney issues, certain medication use, other clinical trials participation, known allergies to the drugs tested, pregnancy, previous strokes or brain injuries.

Inclusion Criteria

I received clot-busting medication within 3 hours after my stroke started.

I can take the study medication within 60 to 75 minutes after starting IV thrombolysis.

You have a score of 6 or higher on the NIH Stroke Scale before receiving IV thrombolytic treatment.

Exclusion Criteria

Informed consent from the patient or the legally authorized representative was not or could not be obtained

Women who could become pregnant have a positive pregnancy test in their urine or blood.

I have taken blood thinners like Fondaparinux, apixaban, or rivaroxaban in the last 2 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive argatroban or eptifibatide or placebo in addition to standard thrombolysis treatment

12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• Argatroban
• Eptifibatide
• Placebo

Trial Overview The MOST trial is testing whether argatroban or eptifibatide improves recovery at 90 days compared to a placebo in patients receiving standard clot-dissolving treatments for stroke. The study also allows additional mechanical clot removal as part of usual care.

Participant Groups

Group I: Eptifibatide Experimental Treatment 1 Intervention

135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours

Group II: Argatroban Experimental Treatment 1 Intervention

100µg/kg bolus followed by 3µg/kg per minute for 12 hours

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+