Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)

Sponsor

Ministry of Science and Technology of the People´s Republic of China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03844594

Collaborator

(none)

220

Enrollment

Location

Arm

20.9

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Eptifibatide Injection	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial

Actual Study Start Date :

Apr 6, 2019

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptifibatide Drug: Eptifibatide Injection	Drug: Eptifibatide Injection 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.

Arm

Intervention/Treatment

Experimental: Eptifibatide Drug: Eptifibatide Injection

Drug: Eptifibatide Injection

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.

Outcome Measures

Primary Outcome Measures

Symptomatic intracranial hemorrhage [Within 48 hours]
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment

Secondary Outcome Measures

Cerebral parenchymal hemorrhage type (PH1) and (PH2) [48 hours]
The incidence of cerebral parenchymal hemorrhage type (PH1) and (PH2) for 48 hours of treatment
Serious adverse events [Within 48 hours]
Proportion of serious adverse events occurring within 48 hours of treatment
Total death rate [Within 48 hours]
Total death rate within 48 hours of treatment
Adverse events [Within 48 hours]
Proportion of adverse events within 48 hours of treatment
Serious adverse events [Within 90 days]
Proportion of serious adverse events within 90 days of treatment
Total death rate [Within 90 days]
Total death rate within 90 days of treatment
Adverse events [Within 90 days]
Proportion of adverse events treated within 90 days
Vascular recanalization [24 hours]
Proportion of vascular recanalization at the first 24 hours during the therapy
Favorable clinical outcomes [90 days]
Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment
Neurological recovery [90 days]
The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS
Recurrent ischemic stroke [90 days]
Proportion of recurrent ischemic stroke after 90 days of treatment
Combined vascular events [90 days]
Proportion of combined vascular events (recurrent ischemic stroke, myocardial infarction and vascular death) at 90 days of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age≥18 years.
Acute ischemic stroke.
Treated with endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, and angioplasty.
Written informed consent obtained from patient or patient's legally authorized representative.

Exclusion Criteria:

Failed to vascular recanalization (mTICI≤1).
Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
Known coagulopathy, Systemic Bleeding Tendency, or baseline platelet count < 100000/mm3.
History of chronic hepatopathy, liver and kidney dysfunction, elevating ALT (> 3 times normal upper limit), elevating serum creatinine (> 2 times normal upper limit).
Patients with severe hypertension (systolic blood pressure > 200mmHg or diastolic blood pressure > 110mmHg).
Known drug or food allergy.
Used other Glycoprotein IIb/IIIa receptor antagonists.
Contraindications for DSA, severe contrast media allergy or iodine contrast media absolute contraindications.
Childbearing age women whose pregnancy tests were negative refused to take effective contraception. Pregnant or lactating or positive pregnancy test on admission.
Incapable to follow this study for mental illness, cognitive or emotional disorder.
The researchers do not consider the participants appropriate to get into this study.