Evaluating Two Dosages of Bevifibatide Injection for Treating Acute Ischemic Stroke Without Large Vessel Blockage in Adults

What this Trial Is About

Researchers are investigating the effects of two different doses of bevifibatide citrate injection for patients who have had an acute ischemic stroke without large or medium-sized vessel blockage. This phase 2, single-center, randomized, double-blind trial aims to find a dose that improves neurological outcomes 90 days after stroke while minimizing the risk of symptomatic brain bleeding and serious side effects. The trial will provide important information to guide future larger studies on dosing. Participants receive bevifibatide citrate injection through an intravenous bolus of 220 mcgkg over 1 to 2 minutes, followed by a continuous intravenous infusion for 24 hours. Two groups receive different maintenance infusion rates one at 2.5 mcgkgmin and the other at 2.0 mcgkgmin. After the infusion and if imaging within 48 hours shows no significant brain bleeding, patients will take aspirin and clopidogrel tablets daily until day 90. Patients are also managed according to current stroke care guidelines, including possible use of low molecular weight heparin for blood clot prevention. During the study, participants will have neurological assessments using the modified Rankin Scale and National Institute of Health Stroke Scale at various time points up to 90 days. Brain scans will monitor for bleeding within 48 hours. Researchers will track adverse events, mortality, platelet aggregation inhibition, and quality of life. Follow-up lasts 90 days after treatment to evaluate both safety and neurological recovery. The total participation duration covers initial treatment and multiple assessments over this period.

A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke