Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)

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

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

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:

  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 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

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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