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

NCT06712004 | Recruiting Phase 2 DMC

• 1 other identifier: LC2024ZD032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bevifibatide citrate injection; Dose-response controlled; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• The modified Rankin Scale (mRS) score

  The mRS scores are evaluated by experienced researchers trained in standard neurological function assessments using information obtained from patients or their families.

  90(±7) days

• Symptomatic intracranial hemorrhage (sICH)

  ICH will be evaluated according to the Heidelberg Bleeding Classification. sICH is diagnosed if the new observed ICH is associated with any of the following conditions: 1) NIHSS score increased more than 4 points than that immediately before worsening; 2) NIHSS score increased more than 2 points in one category; 3) Deterioration led to intubation, hemicraniectomy, external ventricular drain placement or any other major interventions. Additionally, the symptom deteriorations could not be explained by causes other than the observed ICH.

  Within 48 hours

Secondary Outcomes (14)

• mRS score 0-1 at 30 days

  30(±3) days

• mRS score 0-2 at 30 days

  30(±3) days

• mRS score 0-1 at 90 days

  90(±7) days

• mRS score 0-2 at 90 days

  90(±7) days

• Change of the National Institute of Health Stroke Scale (NIHSS) score from baseline to 72 hours

  72(±12) hours

Study Arms (2)

Routine maintenance dose group

EXPERIMENTAL

Undergoing bevifibatide citrate injection with intravenous bolus of 220μg/kg (0.11ml/kg) over 1 to 2 minutes, followed by continuous intravenous bolus at a rate of 2.5μg/kg/min (0.075ml/kg/h) for 24 hours.

Drug: Bevifibatide citrate injection

Low maintenance dose group

EXPERIMENTAL

Undergoing bevifibatide citrate injection with intravenous bolus of 220μg/kg (0.11ml/kg) over 1 to 2 minutes, followed by continuous intravenous bolus at a rate of 2.0μg/kg/min (0.06ml/kg/h) for 24 hours.

Drug: Bevifibatide citrate injection

Interventions

Bevifibatide citrate injection DRUG

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.

Also known as: BETAGRIN

Low maintenance dose group; Routine maintenance dose group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any of the following presentations of acute ischemic stroke (AIS): ① Within 24 hours of time last known well and ineligible for intravenous thrombolysis (IVT) or endovascular treatment (EVT). ② More than 24 hours and less than 96 hours after time last known well but within 24 hours of ischemic stroke progression \[worsening of ≥ 2 points on the NIHSS\]; and ineligible for IVT or EVT without ICH confirmed by CT scan or MRI. ③ Treated with IVT followed by early neurological deterioration (worse NIHSS by ≥ 4 points) within the first 24 hours after IVT without ICH confirmed by CT scan or MRI. ④ Treated with IVT followed by no neurological improvement (Neurological improvement is defined as decrease in the NIHSS score by ≥ 2 points) from baseline within 4 to 24 hours after IVT without ICH confirmed by CT scan or MRI.
• NIHSS score ≥ 3 immediately prior to trial entry.
• Without visible large or medium intracranial vessel occlusion on CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA). (Qualifying mechanisms are: 1. hypoperfusion caused by arterial stenosis; 2. the initial occluded large or medium artery spontaneously recanalized or recanalized with IVT before the vascular imaging performed; 3. multiple or single distal emboli from cardiac or other sources in arterial branches too small to visualized on CTA or MRA; 4. lacunar infarct due to small vessel occlusion).
• Written informed consent obtained from patients or their legal representatives.

You may not qualify if:

• CT or MR evidence of intracranial haemorrhage.
• Pre-morbid disability with a mRS score ≥ 2.
• Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
• Planned treatment with dual antiplatelet therapy within 1week of the index stroke.
• Any history of a primary or other intracerebral (parenchymal) haemorrhage (intraventricular, subarachnoid, subdural, epidural).
• Any untreated or incompletely treated intracranial aneurysm, any intracranial vascular malformation or any intracranial tumour.
• Currently pregnant or lactating, and those planned to conceive.
• Subjects with positive urine HCG test results.
• Known allergy to study medication or concomitant medications.
• Gastrointestinal bleeding, urinary tract bleeding, or other major systemic haemorrhage within 30 days.
• Any major surgery within 6 weeks of the index stroke.
• History of heparin-induced thrombocytopenia.
• Expected lifespan less than 3 months.
• Pre-existing neurological or psychiatric disease that would confound the neurological functional outcome evaluations.
• Any of the following laboratory tests: INR \[International Normalized Ratio\]\>2.0, PT\>1.3 times normal value, platelet count\<100 × 109/L, Hb\<10g/dl.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Infarction; Brain Diseases

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Chuanzhi Duan, MD

  Southern Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Chuanzhi Duan, MD

CONTACT

02062782757; doctor_duanzj@163.com

Xin Feng, MD

CONTACT

13681134001; 13681134001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: February 10, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)