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

NCT06712004 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Chuanzhi Duan, MD · Southern Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712004 on ClinicalTrials.gov