Status:

UNKNOWN

Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)

Lead Sponsor:

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

Conditions:

Acute Ischemic Stroke

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

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, ang...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 6 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2020

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT03844594

Start Date

April 6 2019

End Date

December 31 2020

Last Update

June 18 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH) | DecenTrialz