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.
Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)
Status
Unknown
Phase
Phase 3
Enrollment
220
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 18, 2019
Study start
Apr 6, 2019
Primary completion
Jun 30, 2020
Study completion
Dec 31, 2020
Results posted
Not reported
Registry updated
Jun 18, 2019
Outcomes
What the study measures.
Primary outcomes
Symptomatic intracranial hemorrhage
Time frame · Within 48 hours
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
Secondary outcomes
Cerebral parenchymal hemorrhage type (PH1) and (PH2)
Time frame · 48 hours
The incidence of cerebral parenchymal hemorrhage type (PH1) and (PH2) for 48 hours of treatment
Serious adverse events
Time frame · Within 48 hours
Proportion of serious adverse events occurring within 48 hours of treatment
Total death rate
Time frame · Within 48 hours
Total death rate within 48 hours of treatment
Adverse events
Time frame · Within 48 hours
Proportion of adverse events within 48 hours of treatment
Serious adverse events
Time frame · Within 90 days
Proportion of serious adverse events within 90 days of treatment
Total death rate
Time frame · Within 90 days
Total death rate within 90 days of treatment
Adverse events
Time frame · Within 90 days
Proportion of adverse events treated within 90 days
Vascular recanalization
Time frame · 24 hours
Proportion of vascular recanalization at the first 24 hours during the therapy
Favorable clinical outcomes
Time frame · 90 days
Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment
Neurological recovery
Time frame · 90 days
The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Age≥18 years. 2. Acute ischemic stroke. 3. Treated with endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, and angioplasty. 4. Written informed consent obtained from patient or patient's legally authorized representative. Exclusion Criteria: 1. Failed to vascular recanalization (mTICI≤1). 2. Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on. 3. Known coagulopathy, Systemic Bleeding Tendency, or baseline platelet count \< 100000/mm3. 4. History of chronic hepatopathy, liver and kidney dysfunction, elevating ALT (\> 3 times normal upper limit), elevating serum creatinine (\> 2 times normal upper limit). 5. Patients with severe hypertension (systolic blood pressure \> 200mmHg or diastolic blood pressure \> 110mmHg). 6. Known drug or food allergy. 7. Used other Glycoprotein IIb/IIIa receptor antagonists. 8. Contraindications for DSA, severe contrast media allergy or iodine contrast media absolute contraindications. 9. Childbearing age women whose pregnancy tests were negative refused to take effective contraception. Pregnant or lactating or positive pregnancy test on admission. 10. Incapable to follow this study for mental illness, cognitive or emotional disorder. 11. The researchers do not consider the participants appropriate to get into this study.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
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