Multi-arm Optimization of Stroke Thrombolysis (MOST): 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 safety of argatroban and eptifibatide in combination with IV rt-PA and endovascular thrombectomy will also be assessed.
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. A maximum of 1200 subjects will be enrolled.
The first 150 subjects will be randomized in a 1:1:1 ratio to either argatroban, eptifibatide, or placebo. From the 150th to the 500th subject enrollment, response adaptive randomization (RAR) will favor the active arm showing the greatest benefit based on accrued data. After 500 subjects, one or both intervention arms may be carried forward for fixed randomization versus placebo.