Study 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.
Eligible Conditions
- Stroke
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 2 at 24 hours after randomization
Hour 24
proportion of participants with NIHSS less than or equal to 2 at 24 hours
24 hours after randomization
change from baseline to 24-hour NIHSS
90 days after randomization
90-day EQ-5D
90-day modified Rankin scores (mRS)
90-day ordinal analysis of the mRS
proportion of participants with 90-day mRS 0-1 (or return to their historical mRS)
proportion of participants with 90-day mRS 0-2 (or return to their historical mRS)
baseline
proportion of participants who have thrombectomy
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Argatroban
1 of 3
Eptifibatide
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
1200 Total Participants · 3 Treatment Groups
Primary Treatment: Argatroban · Has Placebo Group · Phase 3
Argatroban
Drug
Experimental Group · 1 Intervention: Argatroban · Intervention Types: DrugEptifibatide
Drug
Experimental Group · 1 Intervention: Eptifibatide · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Argatroban
FDA approved
Eptifibatide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 at 24 hours after randomization
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,277,415 Total Patients Enrolled
22 Trials studying Stroke
76,204 Patients Enrolled for Stroke
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,261 Previous Clinical Trials
453,762 Total Patients Enrolled
163 Trials studying Stroke
82,145 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
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a NIHSS score of 6 or more.
Who else is applying?
What state do they live in?
| New York | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Deeds, S Iris, Andrew Barreto, Jordan Elm, Colin P Derdeyn, Scott Berry, Pooja Khatri, Claudia Moy, et al.. 2020. “The Multiarm Optimization of Stroke Thrombolysis Phase 3 Acute Stroke Randomized Clinical Trial: Rationale and Methods”. International Journal of Stroke. SAGE Publications. doi:10.1177/1747493020978345.
- Opeolu Makanju Adeoye 2019. "Multi-arm Optimization of Stroke Thrombolysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03735979.
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Conditions
Cancer Related
Treatments