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Ischemic Stroke, AcutePhase 2BCAIS-INCT06712004

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

A Phase 2 study testing Bevifibatide citrate injection in people with Ischemic Stroke, Acute and Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Bevifibatide citrate injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Feb 2025to 1 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.
  • Systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg after aggressive treatment.
  • Severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 μmol/L [2.5 mg/dl]).
  • History of liver dysfunction (AST/ALT exceeding the upper limit of normal by more than twice) or cirrhosis.
  • Arterial tortuosity and/or other arterial diseases that prevent the expected internal thrombectomy device from reaching the target vessel.
  • Unlikely to be available for 90-day follow-up.
  • Current participation in another treatment clinical trial.
  • Other conditions that are not suitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chuanzhi Duan, MD contact

02062782757

doctor_duanzj@163.com

Xin Feng, MD contact

13681134001

13681134001@163.com

China1 site, 1 recruiting
  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Chuanzhi Duan, MD, 02062782757, doctor_duanzj@163.com

    Xin Feng, MD, 13681134001, 13681134001@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Bevifibatide is a derivative similar to Eptifibatide, differing by only one amino acid: in the position where Eptifibatide contains high arginine, it is replaced by arginine to form Bevifibatide. Bevifibatide can specifically bind to the GPIIb/IIIa receptor, inhibiting platelet aggregation or adhesion. It also inhibits the integrin receptor αvβ3, thereby suppressing the growth of vascular smooth muscle and playing an important role in preventing arterial re-occlusion. Bevifibatide is a post-marketing product indicated for unstable angina, non-Q wave myocardial infarction, non-ST segment elevation myocardial infarction, and anti-thrombotic therapy during and around percutaneous coronary intervention. Its clinical formulation is an injectable solution for intravenous administration. When Bevifibatide is used in combination with clinical baseline medications, it has a synergistic effect on anti-platelet aggregation. Early oral administration of aspirin and clopidogrel can achieve a rapid synergistic effect on anti-platelet aggregation.

Currently, there are no clinical trials assessing the relationship between the dosage of Bevifibatide and its efficacy in treating acute ischemic stroke. We conduct a single-center, randomized, double-blind, dose-response controlled clinical trial to preliminarily evaluate and compare the effectiveness of conventional dosage and low maintenance dosage of Bevifibatide citrate injection in improving neurological outcomes at 90 days and the incidence of symptomatic intracranial hemorrhage in patients suffering from acute ischemic stroke without large or medium-sized vessel occlusion, thereby determining a relatively safe dosage while maintaining the effectiveness of the medication, and providing a dosage basis for conducting large-sample randomized controlled trials.

Being tested
Bevifibatide citrate injection
Keywords
Bevifibatide citrate injection, Dose-response controlled, Acute Ischemic Stroke
Medical subject headings
Ischemic Stroke, Cerebral Infarction, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevifibatide citrate injectionDrug

    Also called BETAGRIN

    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.

Study groups in NCT06712004
Study groupRoleWhat they receive
Routine maintenance dose groupExperimentalUndergoing 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.
Receives: Drug: Bevifibatide citrate injection
Low maintenance dose groupExperimentalUndergoing 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.
Receives: Drug: Bevifibatide citrate injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Within 48 hours

Secondary outcomes (14)
  1. mRS score 0-1 at 30 days

    Proportion of patients without disability at 30 days.

    Measured: 30(±3) days

  2. mRS score 0-2 at 30 days

    Proportion of patients with functional independence at 30 days.

    Measured: 30(±3) days

  3. mRS score 0-1 at 90 days

    Proportion of patients without disability at 90 days.

    Measured: 90(±7) days

  4. mRS score 0-2 at 90 days

    Proportion of patients with functional independence at 90 days.

    Measured: 90(±7) days

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

    Change of the NIHSS score from baseline to 72 hours

    Measured: 72(±12) hours

  6. Change of the NIHSS score from baseline to 6 days

    Change of the NIHSS score from baseline to 6 days

    Measured: 6(±1) days

  7. Change of the NIHSS score from baseline to 90 days

    Change of the NIHSS score from baseline to 90 days

    Measured: 90(±7) days

  8. Health-related quality of life

    Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)

    Measured: 90(±7) days

  9. Any ICH

    ICH will be evaluated according to the Heidelberg Bleeding Classification.

    Measured: Within 48 hours

  10. Mortality

    Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.

    Measured: 90(±7) days

  11. Incidence of serious adverse events

    Including both bleeding and non-bleeding adverse events. Among these, bleeding adverse events encompass: purpura, minor oral and nasal mucosal bleeding, ecchymosis, gingival bleeding, epistaxis, minor gastrointestinal or urinary tract bleeding, hematomas from spontaneous or minor trauma, hemarthrosis, intracranial hemorrhage, and bleeding that poses hemodynamic compromise or requires intervention.

    Serious adverse events are defined as undesirable medical events that occur after a subject has received the investigational product, including death, life-threatening conditions, permanent or significant disability, or loss of function, hospitalization or prolongation of hospital stay due to the event, and congenital anomalies or birth defects.

    Measured: 90(±7) days

  12. Incidence of adverse events

    Including both bleeding and non-bleeding adverse events. Among these, bleeding adverse events encompass: purpura, minor oral and nasal mucosal bleeding, ecchymosis, gingival bleeding, epistaxis, minor gastrointestinal or urinary tract bleeding, hematomas from spontaneous or minor trauma, hemarthrosis, intracranial hemorrhage, and bleeding that poses hemodynamic compromise or requires intervention.

    Adverse events are defined as any harmful or unintended responses occurring in a clinical trial that may be related to the investigational product. There should be at least a reasonable possibility of a causal relationship between the study product and the adverse reaction, meaning that a connection cannot be ruled out.

    Measured: 90(±7) days

  13. Inhibitory rate of platelet aggregation at 4 hours

    ADP-induced platelet aggregation.

    Measured: 4 hours

  14. Inhibitory rate of platelet aggregation at 24 hours

    ADP-induced platelet aggregation.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start10 Feb 2025
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712004
Sponsor's protocol ID
LC2024ZD032
Acronym
BCAIS-I
Status last verified
Nov 2024
First submitted
27 Nov 2024
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevifibatide citrate injection in people with Ischemic Stroke, Acute and Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chuanzhi Duan, MD (02062782757, doctor_duanzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The modified Rankin Scale (mRS) score (time frame: 90(±7) days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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