Actively Recruiting
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
Led by Zhujiang Hospital · Updated on 2025-07-17
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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 mcg/kg 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 mcg/kg/min and the other at 2.0 mcg/kg/min. 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.
CONDITIONS
Brief Title
A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Acute ischemic stroke within 24 hours of symptom onset and ineligible for intravenous thrombolysis or endovascular treatment; or 24 to 96 hours after onset with stroke progression but no intracranial hemorrhage confirmed by imaging
- NIHSS score of 3 or higher before trial entry
- No large or medium intracranial vessel occlusion visible on vascular imaging
- Written informed consent from patient or legal representative
You will not qualify if you...
- Evidence of intracranial hemorrhage on CT or MRI
- Pre-stroke disability with modified Rankin Scale score of 2 or higher
- Certain heart conditions causing embolism, such as atrial fibrillation or recent myocardial infarction
- Planned dual antiplatelet therapy within 1 week of stroke
- History of any brain hemorrhage or untreated brain aneurysm, vascular malformation, or tumor
- Pregnancy, lactation, or planning to conceive; positive pregnancy test
- Allergy to study or concomitant medications
- Major bleeding within 30 days or major surgery within 6 weeks
- History of heparin-induced thrombocytopenia
- Expected life expectancy less than 3 months
- Pre-existing neurological or psychiatric disease affecting outcomes
- Abnormal blood clotting tests or very low platelet count
- High blood pressure despite treatment
- Severe kidney or liver dysfunction
- Arterial diseases preventing thrombectomy device use
- Unlikely to be available for 90-day follow-up
- Current participation in another treatment clinical trial
- Other conditions unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive an intravenous infusion of Bevifibatide citrate injection with a bolus followed by continuous infusion for 24 hours. After confirming no significant intracranial hemorrhage within 48 hours by cranial imaging, participants start daily aspirin and clopidogrel tablets until day 90.
1 baseline visit and follow-up visits within 48 hours and at 30 and 90 days
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
Research Team
C
Chuanzhi Duan, MD
X
Xin Feng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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