Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06712004

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

Led by Zhujiang Hospital · Updated on 2025-07-17

40

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Acute ischemic stroke within 24 hours of last known well and not eligible for intravenous thrombolysis or endovascular treatment
  • Stroke progression between 24 and 96 hours after last known well but within 24 hours of worsening symptoms and ineligible for thrombolysis or endovascular treatment
  • Treated with intravenous thrombolysis followed by early neurological deterioration or no improvement within 24 hours without intracranial hemorrhage
  • NIHSS score of 3 or higher immediately before trial entry
  • No visible large or medium intracranial vessel occlusion on angiographic imaging
  • Signed informed consent obtained from patient or legal representative
Not Eligible

You will not qualify if you...

  • Evidence of intracranial hemorrhage on CT or MRI
  • Pre-existing disability with modified Rankin Scale score of 2 or higher
  • Certain cardiac sources of embolism including atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, recent myocardial infarction, dilated cardiomyopathy, left atrial echo contrast, or low ejection fraction
  • Planned dual antiplatelet therapy within 1 week of stroke
  • History of any primary or other intracerebral hemorrhage
  • Untreated intracranial aneurysm, vascular malformation, or brain tumor
  • Pregnancy, lactation, or positive pregnancy test
  • Known allergy to study or related medications
  • Major bleeding within 30 days
  • Major surgery within 6 weeks
  • History of heparin-induced thrombocytopenia
  • Expected lifespan less than 3 months
  • Pre-existing neurological or psychiatric disease affecting outcome evaluations
  • Abnormal laboratory values including elevated INR, PT, low platelets, or low hemoglobin
  • High blood pressure despite treatment (systolic >180 mmHg or diastolic >110 mmHg)
  • Severe kidney or liver dysfunction
  • Arterial diseases preventing device access
  • Unlikely to complete 90-day follow-up
  • Currently enrolled in another treatment trial
  • Other unsuitable medical conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

Actively Recruiting

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Research Team

C

Chuanzhi Duan, MD

CONTACT

X

Xin Feng, MD

CONTACT

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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