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NCT03735979 · ClinicalTrials.gov registry record · Phase 3
Multi-arm Optimization of Stroke Thrombolysis
A Phase 3 study of Acute Ischemic Stroke, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
- 20
- Study locations
NCT03735979: Completed Phase 3 study of Acute Ischemic Stroke, sponsored by Washington University School of Medicine.
NCT03735979 is a Phase 3 study of Acute Ischemic Stroke that has completed, run by Washington University School of Medicine. The registered enrollment target is 514 participants, above the 331-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03735979, a Phase 3 study of Acute Ischemic Stroke, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The modified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms" to 6="death" . For the primary analysis, the scale was analyzed with patient-centered utility weights. We assigned the following utility weights to the seven levels: 10, 9.1,, 7.6, 6.5, 3.3, 0, 0 (with higher scores indicating a better outcome).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Argatroban
- DRUG Eptifibatide
Study Locations (20)
California
- St. Jude Medical Center - Fullerton
- UCSD Health La Jolla - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- UC Irvine Medical Center - Orange
- UCSD Medical Center - Hillcrest Hospital - San Diego
- San Francisco General Hospital - San Francisco
- UCSF Medical Center - San Francisco
- Santa Barbara Cottage Hospital - Santa Barbara
Florida
- Baptist Medical Center Jacksonville - Jacksonville
- Mayo Clinic Hospital - Jacksonville
- Jackson Memorial Hospital - Miami
- Sarasota Memorial Hospital - Sarasota
- Tampa General Hospital - Tampa
Illinois
- University of Chicago Medical Center - Chicago
- Loyola University Medical Center - Maywood
- Javon Bea Hospital - Riverside - Rockford
Alabama
- University of Alabama Hospital - Birmingham
Connecticut
- Yale New Haven Hospital - New Haven
Georgia
- Grady Memorial Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 3 |
What the finished NCT03735979 record still lists
NCT03735979 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, above the 331-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03735979 names 20 study sites across 6 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03735979 about?
NCT03735979 is a clinical study titled "Multi-arm Optimization of Stroke Thrombolysis". 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 placeb...
What is the current status of trial NCT03735979?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2019-10-15. Estimated completion is 2024-10-31.
What conditions does trial NCT03735979 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke.
What interventions are being tested in trial NCT03735979?
The interventions under investigation include: Placebo (DRUG), Argatroban (DRUG), Eptifibatide (DRUG).
Who is sponsoring clinical trial NCT03735979?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03735979 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03735979's enrollment target sits among peer trials
514 7th of 25 higher than 18 of 25 other Acute Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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