NEWS & PRESS RELEASE: https://www.bizjournals.com/cincinnati/news/2018/06/01/uc-lands-largest-grant-ever-for-emergency-medicine.html
The goal of this study is to determine the effectiveness of combining a drug known as tissue plasminogen activator, or tPA, with blood thinners argatroban or eptifibatide. The research will look at whether combining tPA with either argatroban or eptifibatide will produce better results in stroke patients in the first 90 days after suffering a stroke versus tPA with a placebo.
The plan is for 110 hospitals to take part in the study through NIH StrokeNet, the University of Cincinnati based National Coordinating Center for all stroke trials funded by the National Institute of Neurological Disorders and Stroke.
Trial Design and Outcomes:
This is a three-arm, adaptive, Phase-3, blinded, randomized controlled clinical trial at approximately 110 sites in the United States. The first 150 subjects will be randomized in a 1:1:1 to treatment. From 150-500 patients, response adaptive randomization (RAR) will favor the treatment arm showing the greatest benefit based on accrued data. After 500 patients, one or both intervention arms may be carried forward for fixed randomization versus IV tPA. A maximum of 1200 patients will be enrolled.
Eligible patients will be aged 18 or older, receive IV tPA within three hours of symptom onset, and receive study drug (placebo, argatroban or eptifibatide) within an hour of IV tPA. Endovascular therapy will be per standard of care as needed.
The primary safety objective of the MOST trial is to determine the safety of combining IV tPA with argatroban or eptifibatide as compared to IV tPA alone, as measured by symptomatic intracranial hemorrhage (sICH) within 36 hours from onset.
- Study Aim: Confirm safety and establish efficacy of IV tPA plus IV argatroban OR IV tPA plus IV eptifibatide over standard IV tPA alone for acute ischemic stroke
- Primary Efficacy Endpoint: 90-day functional outcome as measured by the mRS translated into utilities
- Primary Safety Endpoint: sICH rate (overall and ET-specific)
Study Sponsor and Chair:
Opeolu Adeoye, MD MS (Lead), University of Cincinnati
Andrew Barreto, MD MS, University of Texas Houston
Joseph Broderick, MD, University of Cincinnati
Colin Derdeyn MD, University of Iowa
James Grotta, MD, Memorial Hermann Hospital Houston
The National Institute of Neurological Disorders and Stroke (NINDS) - 1U01NS100699-01A1
NIH StrokeNet National Coordinating Center at the University of Cincinnati
NIH StrokeNet National Data Management Center at Medical University of South Carolina
US FDA: IND # 63550
For More information:
Department of Emergency Medicine
University of Cincinnati
231 Albert Sabin Way
Cincinnati, OH 45267
Telephone: S. Iris Deeds, CCRP @ 513-558-8627
ClinicalTrials.gov Identifier: NCT03735979