The study is a single-arm, open-label, multicenter clinical trial.The primary purpose of this trial is to evaluate the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke within 48 hours after the use of Eptifibatide injection. Patients with acute ischemic stroke treated with intravascular thrombolytic therapy, mechanical thrombolysis, angioplasty and so on were treated with Eptifibatide injection on the first day, followed by the second day, the third day, the discharge day and the 90 days.
The study is a single-arm, open-label, multicenter clinical trial.A total of 220 patients (Age≥18years) with acute ischemic stroke treated with intravascular thrombolysis, mechanical thrombolysis, angioplasty, etc., were treated with Eptifibatide, providing informed consent and medication.The recommended dose of this study was: first, 135ug / kg was injected intravenously or intraductal (within 5 minutes), followed by continuous intravenous infusion of 0.75 ug / kg / min for 24 h. In special cases, it is up to the operator to decide whether to reinject or increase the dosage according to experience. The maximum dose for the first time was 180ug / kg, if necessary, with a 10-minute interval of intravenously or intraductal injection, and a maximum dose of 180ug / kg, intravenously / intraductal injection of no more than 360ug / kg. Continuous intravenous infusion does not exceed 2ug/kg/ Min. Then the second day, the third day, the discharge and 90 days visit. Follow-up information included vital signs and physical examination, observation of symptomatic intracranial hemorrhage, NIHSS scale, and recording of current drug use by AE,SAE.The trial is anticipated to last from January 2019 to December 2019 with 220 subjects recruited form 15 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Recommendation: first, intravenously or intraductal injection of 135ug / kg (completed in 5 minutes), followed by continuous intravenous infusion of 0.75ug / kg / min for 24 hours.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGSymptomatic intracranial hemorrhage
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
Time frame: Within 48 hours
Cerebral parenchymal hemorrhage type (PH1) and (PH2)
The incidence of cerebral parenchymal hemorrhage type (PH1) and (PH2) for 48 hours of treatment
Time frame: 48 hours
Serious adverse events
Proportion of serious adverse events occurring within 48 hours of treatment
Time frame: Within 48 hours
Total death rate
Total death rate within 48 hours of treatment
Time frame: Within 48 hours
Adverse events
Proportion of adverse events within 48 hours of treatment
Time frame: Within 48 hours
Serious adverse events
Proportion of serious adverse events within 90 days of treatment
Time frame: Within 90 days
Total death rate
Total death rate within 90 days of treatment
Time frame: Within 90 days
Adverse events
Proportion of adverse events treated within 90 days
Time frame: Within 90 days
Vascular recanalization
Proportion of vascular recanalization at the first 24 hours during the therapy
Time frame: 24 hours
Favorable clinical outcomes
Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment
Time frame: 90 days
Neurological recovery
The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS
Time frame: 90 days
Recurrent ischemic stroke
Proportion of recurrent ischemic stroke after 90 days of treatment
Time frame: 90 days
Combined vascular events
Proportion of combined vascular events (recurrent ischemic stroke, myocardial infarction and vascular death) at 90 days of treatment
Time frame: 90 days
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