- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844594
Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)
June 16, 2019 updated by: Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China
Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
220
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhongrong Miao, PHD,MD
- Phone Number: 0086-10-59975211
- Email: zhongrongm@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100070
- Recruiting
- Beijing Tiantan Hospital
-
Contact:
- Zhongrong Miao, MD,Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Eptifibatide 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic intracranial hemorrhage
Time Frame: Within 48 hours
|
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
|
Within 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
48 hours
|
Serious adverse events
Time Frame: Within 48 hours
|
Proportion of serious adverse events occurring within 48 hours of treatment
|
Within 48 hours
|
Total death rate
Time Frame: Within 48 hours
|
Total death rate within 48 hours of treatment
|
Within 48 hours
|
Adverse events
Time Frame: Within 48 hours
|
Proportion of adverse events within 48 hours of treatment
|
Within 48 hours
|
Serious adverse events
Time Frame: Within 90 days
|
Proportion of serious adverse events within 90 days of treatment
|
Within 90 days
|
Total death rate
Time Frame: Within 90 days
|
Total death rate within 90 days of treatment
|
Within 90 days
|
Adverse events
Time Frame: Within 90 days
|
Proportion of adverse events treated within 90 days
|
Within 90 days
|
Vascular recanalization
Time Frame: 24 hours
|
Proportion of vascular recanalization at the first 24 hours during the therapy
|
24 hours
|
Favorable clinical outcomes
Time Frame: 90 days
|
Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment
|
90 days
|
Neurological recovery
Time Frame: 90 days
|
The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS
|
90 days
|
Recurrent ischemic stroke
Time Frame: 90 days
|
Proportion of recurrent ischemic stroke after 90 days of treatment
|
90 days
|
Combined vascular events
Time Frame: 90 days
|
Proportion of combined vascular events (recurrent ischemic stroke, myocardial infarction and vascular death) at 90 days of treatment
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 6, 2019
Primary Completion (ANTICIPATED)
June 30, 2020
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
February 15, 2019
First Posted (ACTUAL)
February 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 16, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Platelet Aggregation Inhibitors
- Eptifibatide
Other Study ID Numbers
- 2019EPOCH19011912
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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