NCT06712004

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

Efficacy and Safety of Bevifibatide Citrate Injection in Patients With Acute Ischemic Stroke Without Large or Medium-Sized Vessel Occlusion: A Single-Center, Randomized, Double-Blind, Dose-Response Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

BCAIS-I is a single-center, randomized, double-blind, dose-response controlled clinical Trial, to preliminarily explore the efficacy of two different maintenance doses of bevifibatide citrate injection in improving 90-day neurological outcomes and the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke without large or medium-sized vessel occlusion, aiming to identify a dosing regimen that maintains therapeutic efficacy while minimizing the rates of symptomatic intracranial hemorrhage and serious adverse events, thereby providing dosing evidence for future large-scale randomized controlled trials.

Detailed description

Bevifibatide is a derivative similar to Eptifibatide, differing by only one amino acid: in the position where Eptifibatide contains high arginine, it is replaced by arginine to form Bevifibatide. Bevifibatide can specifically bind to the GPIIb/IIIa receptor, inhibiting platelet aggregation or adhesion. It also inhibits the integrin receptor αvβ3, thereby suppressing the growth of vascular smooth muscle and playing an important role in preventing arterial re-occlusion. Bevifibatide is a post-marketing product indicated for unstable angina, non-Q wave myocardial infarction, non-ST segment elevation myocardial infarction, and anti-thrombotic therapy during and around percutaneous coronary intervention. Its clinical formulation is an injectable solution for intravenous administration. When Bevifibatide is used in combination with clinical baseline medications, it has a synergistic effect on anti-platelet aggregation. Early oral administration of aspirin and clopidogrel can achieve a rapid synergistic effect on anti-platelet aggregation. Currently, there are no clinical trials assessing the relationship between the dosage of Bevifibatide and its efficacy in treating acute ischemic stroke. We conduct a single-center, randomized, double-blind, dose-response controlled clinical trial to preliminarily evaluate and compare the effectiveness of conventional dosage and low maintenance dosage of Bevifibatide citrate injection in improving neurological outcomes at 90 days and the incidence of symptomatic intracranial hemorrhage in patients suffering from acute ischemic stroke without large or medium-sized vessel occlusion, thereby determining a relatively safe dosage while maintaining the effectiveness of the medication, and providing a dosage basis for conducting large-sample randomized controlled trials.

Conditions

• Ischemic Stroke, Acute
• Ischemic Stroke
• Cerebral Infarction
• Brain Diseases

Interventions

Type	Name	Description
DRUG	Bevifibatide citrate injection	Bevifibatide citrate injection should be diluted with 0.9% NaCl solution. After the completion of the study drug infusion, if a follow-up cranial NCCT/MRI within 48 hours shows no significant intracranial hemorrhage, all patients will be administered enteric-coated aspirin tablets (100mg, qd) and clopidogrel hydrogen sulfate tablets (75mg, qd) until day 90. All patients will be managed in accordance with the current guidelines for stroke management. The use of low molecular weight heparin for the prevention of deep vein thrombosis is permitted.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-12-02
• Last updated: 2025-07-17

Locations

1 site across 1 country: China