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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after randomization
Awards & highlights
MOST 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.Check my eligibility
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.See study design
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.
MOST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I received clot-busting medication within 3 hours after my stroke started.
Select...
I can take the study medication within 60 to 75 minutes after starting IV thrombolysis.
Select...
I have had a recent stroke caused by a blood clot.
Select...
I am 18 years old or older.
MOST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
90-day modified Rankin scores (mRS)
Secondary outcome measures
90-day EQ-5D
90-day ordinal analysis of the mRS
change from baseline to 24-hour NIHSS
+4 moreMOST 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
~2260
Eptifibatide
2014
Completed Phase 4
~14650
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,195 Total Patients Enrolled
23 Trials studying Stroke
76,289 Patients Enrolled for Stroke
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
648,876 Total Patients Enrolled
171 Trials studying Stroke
83,344 Patients Enrolled for Stroke
Opeolu Adeoye, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Stroke
27 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received clot-busting medication within 3 hours after my stroke started.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.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.I have had a stroke within the last 3 months.I have a bleeding disorder or take blood thinners with an INR over 1.5.My CT scan shows a large area of damage in my brain's middle region.I have not had any surgery or biopsy on an organ in the last 30 days.I have not had a serious bleeding issue in the last 30 days.I am currently on kidney dialysis.I have taken medication for blood clots within the last 2 weeks.I have had a brain bleed, tumor, or abnormal blood vessel formation.I was suspected to have a brain bleed despite a normal initial CT scan.My blood pressure remains high (>180mmHg) after treatment for a clot.Your hematocrit level is less than 25%.I am not currently in a drug or device trial, or it has been over 90 days since I last participated.My blood clotting test was abnormal after taking certain blood thinners.You had a serious head injury in the last 90 days.My blood pressure remains high after treatment.Your blood sugar level is lower than 50 or higher than 400 mg/dl.I have had a recent stroke caused by a blood clot.You have a dense area in your body that shows signs of bleeding.Your platelet count is less than 100,000 per cubic millimeter.Your blood clotting test (PTT) shows higher levels than normal.I do not have any serious illnesses that would make specific treatments risky for me.I do not have a severe neurological or psychiatric condition that affects my daily activities.I have had internal injuries or open sores from an injury in the last month.I have taken a full dose of a blood thinner like Dalteparin, Enoxaparin, or Tinzaparin in the last 24 hours.I am 18 years old or older.Your creatinine level is higher than 4 mg/dl.You are allergic to argatroban or eptifibatide.
Research Study Groups:
This trial has the following groups:- Group 1: Argatroban
- Group 2: Eptifibatide
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling patients for this test?
"Yes, this trial is still open to patients according to the listing on clinicaltrials.gov. The posting went up on 2019-10-15 and was edited as recently as 2022-06-06."
Answered by AI
What other similar trials have preceded this one?
"There are 5 ongoing clinical trials for Argatroban in 94 cities and 12 countries. The first clinical trial was completed in 2019 by Aspen Global Incorporated. That study reached Phase 3 approval after 508 patients were enrolled. In the two years since, 18264 trials have been completed."
Answered by AI
What other investigations have been conducted with Argatroban?
"Argatroban was first studied in 2019 at the Regional Hospital after N.N Burdenko. So far, there have been 18264 completed clinical trials. There are 5 trials currently recruiting, with a large concentration of these studies based in Los Angeles, California."
Answered by AI
Are there any mortal risks associated with Argatroban?
"Argatroban's safety is well-documented, as this is a Phase 3 trial."
Answered by AI
Is this a widespread trial or limited to a few hospitals?
"This study is enrolling patients at multiple sites across the United States, including the Kaiser Permanente Los Angeles Medical Center in Los Angeles, California, the Baptist Medical Center Jacksonville in Jacksonville, Florida, and the Jackson Memorial Hospital in Miami, Ohio."
Answered by AI
What are the main medical conditions that Argatroban is used to manage?
"Argatroban is indicated for the treatment of acute chest syndrome, thrombosis prophylaxis, and percutaneous coronary intervention (pci)."
Answered by AI
How many people can join this experiment at most?
"That is correct. The online clinical trial registry lists this study as open and currently recruiting patients. This trial was first posted on 2019-10-15 and was most recently edited on 2022-06-06. They are looking for a total of 1200 participants across 76 sites."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Other
New York
Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Baptist Medical Center Jacksonville
Why did patients apply to this trial?
I had a stroke 18 months ago. I want to help others who suffered a stroke.
PatientReceived no prior treatments
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