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Direct Thrombin Inhibitor

Blood Clot Treatments for Stroke (MOST Trial)

Phase 3
Waitlist Available
Led By Opeolu Adeoye, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis
Must not have
Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours
Previous stroke in the past 90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 hours after randomization
Awards & highlights
Pivotal Trial

Summary

This trial is comparing two different blood clot treatments to see which one results in better outcomes for patients who have had a stroke.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include bleeding complications due to the anti-clotting nature of argatroban and eptifibatide. Other risks could involve allergic reactions to these medications and possible interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received clot-busting medication within 3 hours after my stroke started.
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I can take the study medication within 60 to 75 minutes after starting IV thrombolysis.
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I have had a recent stroke caused by a blood clot.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken blood thinners like Fondaparinux, apixaban, or rivaroxaban in the last 2 days.
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I have had a stroke within the last 3 months.
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My CT scan shows a large area of damage in my brain's middle region.
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I have not had any surgery or biopsy on an organ in the last 30 days.
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I have not had a serious bleeding issue in the last 30 days.
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I am currently on kidney dialysis.
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I have had a brain bleed, tumor, or abnormal blood vessel formation.
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I was suspected to have a brain bleed despite a normal initial CT scan.
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My blood pressure remains high (>180mmHg) after treatment for a clot.
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My blood clotting test was abnormal after taking certain blood thinners.
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I have a bleeding disorder or take blood thinners with an INR over 1.5.
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My blood pressure remains high after treatment.
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I do not have a severe neurological or psychiatric condition that affects my daily activities.
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I have taken a full dose of a blood thinner like Dalteparin, Enoxaparin, or Tinzaparin in the last 24 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
90-day Utility Weighted Modified Rankin Scores (UW-mRS)
Secondary study objectives
90-day EQ-5D
90-day mRS
Change From Baseline to 24-hour NIHSS
+5 more
Other study objectives
Any Intracranial Hemorrhage Within 36 Hours (Safety Outcome)
Other Major Hemorrhage Other Than Intracranial Hemorrhage Within 7 Days (Safety Outcome)
Symptomatic Intracranial Hemorrhage Within 36 Hours (Primary Safety Outcome)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EptifibatideExperimental Treatment1 Intervention
135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours
Group II: ArgatrobanExperimental Treatment1 Intervention
100µg/kg bolus followed by 3µg/kg per minute for 12 hours
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Argatroban
2018
Completed Phase 4
~2300
Eptifibatide
2014
Completed Phase 4
~14650

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,343,748 Total Patients Enrolled
23 Trials studying Stroke
76,289 Patients Enrolled for Stroke
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,174 Total Patients Enrolled
179 Trials studying Stroke
80,977 Patients Enrolled for Stroke
Opeolu Adeoye, MDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
2,027 Total Patients Enrolled
2 Trials studying Stroke
2,027 Patients Enrolled for Stroke

Media Library

Argatroban (Direct Thrombin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03735979 — Phase 3
Stroke Research Study Groups: Argatroban, Eptifibatide, Placebo
Stroke Clinical Trial 2023: Argatroban Highlights & Side Effects. Trial Name: NCT03735979 — Phase 3
Argatroban (Direct Thrombin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03735979 — Phase 3
~83 spots leftby Dec 2025
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