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

ConditionsIschemic Stroke, AcuteIschemic StrokeCerebral InfarctionBrain Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhujiang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Routine maintenance dose groupExperimental treatment 1 intervention
Group B: Low maintenance dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90(±7) days
2

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.

Time frame
Within 48 hours

Secondary outcomes

1

mRS score 0-1 at 30 days

Proportion of patients without disability at 30 days.

Time frame
30(±3) days
2

mRS score 0-2 at 30 days

Proportion of patients with functional independence at 30 days.

Time frame
30(±3) days
3

mRS score 0-1 at 90 days

Proportion of patients without disability at 90 days.

Time frame
90(±7) days
4

mRS score 0-2 at 90 days

Proportion of patients with functional independence at 90 days.

Time frame
90(±7) days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

Source ClinicalTrials.gov
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