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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score 0-1 at 30 days | Proportion of patients without disability at 30 days. | 30(±3) days |
| mRS score 0-2 at 30 days | Proportion of patients with functional independence at 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanzhi Duan, MD | Contact | 02062782757 | doctor_duanzj@163.com | |
| Xin Feng, MD | Contact | 13681134001 | 13681134001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanzhi Duan, MD | Southern Medical University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002544 | Cerebral Infarction |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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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.
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| 30(±3) days |
| mRS score 0-1 at 90 days | Proportion of patients without disability at 90 days. | 90(±7) days |
| mRS score 0-2 at 90 days | Proportion of patients with functional independence at 90 days. | 90(±7) days |
| 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 | 72(±12) hours |
| Change of the NIHSS score from baseline to 6 days | Change of the NIHSS score from baseline to 6 days | 6(±1) days |
| Change of the NIHSS score from baseline to 90 days | Change of the NIHSS score from baseline to 90 days | 90(±7) days |
| Health-related quality of life | Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) | 90(±7) days |
| Any ICH | ICH will be evaluated according to the Heidelberg Bleeding Classification. | Within 48 hours |
| Mortality | Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period. | 90(±7) days |
| 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. | 90(±7) days |
| 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. | 90(±7) days |
| Inhibitory rate of platelet aggregation at 4 hours | ADP-induced platelet aggregation. | 4 hours |
| Inhibitory rate of platelet aggregation at 24 hours | ADP-induced platelet aggregation. | 24 hours |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |