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Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)

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ClinicalTrials.gov Identifier: NCT03844594
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Symptomatic intracranial hemorrhage [ Time Frame: Within 48 hours ]
    Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment


Secondary Outcome Measures :
  1. 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

  2. Serious adverse events [ Time Frame: Within 48 hours ]
    Proportion of serious adverse events occurring within 48 hours of treatment

  3. Total death rate [ Time Frame: Within 48 hours ]
    Total death rate within 48 hours of treatment

  4. Adverse events [ Time Frame: Within 48 hours ]
    Proportion of adverse events within 48 hours of treatment

  5. Serious adverse events [ Time Frame: Within 90 days ]
    Proportion of serious adverse events within 90 days of treatment

  6. Total death rate [ Time Frame: Within 90 days ]
    Total death rate within 90 days of treatment

  7. Adverse events [ Time Frame: Within 90 days ]
    Proportion of adverse events treated within 90 days

  8. Vascular recanalization [ Time Frame: 24 hours ]
    Proportion of vascular recanalization at the first 24 hours during the therapy

  9. Favorable clinical outcomes [ Time Frame: 90 days ]
    Proportion of patients achieve favorable clinical outcomes (mRS 0-2) after 90 days of treatment

  10. Neurological recovery [ Time Frame: 90 days ]
    The recovery of neurological deficits assessed by the difference of the 90 days NIHSS to the baseline NIHSS

  11. Recurrent ischemic stroke [ Time Frame: 90 days ]
    Proportion of recurrent ischemic stroke after 90 days of treatment

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844594


Contacts
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Contact: Zhongrong Miao, PHD,MD 0086-10-59975211 zhongrongm@163.com

Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China

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Responsible Party: Zhongrong Miao, Chief of Department of Neurological Intervention, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03844594     History of Changes
Other Study ID Numbers: 2019EPOCH19011912
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
Acute Ischemic Stroke
Eptifibatide
Endovascular Treatment
Recovery of Dysfunction

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Eptifibatide