Clinical trial NCT03844594: Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)
Official title: Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Eptifibatide
Endovascular Treatment
Recovery of Dysfunction
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2019-02-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Symptomatic intracranial hemorrhage
timeFrame: Within 48 hours
Secondary outcomes:
measure: Cerebral parenchymal hemorrhage type (PH1) and (PH2)
timeFrame: 48 hours
measure: Serious adverse events
timeFrame: Within 48 hours
measure: Total death rate
timeFrame: Within 48 hours
measure: Adverse events
timeFrame: Within 48 hours
measure: Serious adverse events
timeFrame: Within 90 days
measure: Total death rate
timeFrame: Within 90 days
measure: Adverse events
timeFrame: Within 90 days
measure: Vascular recanalization
timeFrame: 24 hours
measure: Favorable clinical outcomes
timeFrame: 90 days
measure: Neurological recovery
timeFrame: 90 days
measure: Recurrent ischemic stroke
timeFrame: 90 days
measure: Combined vascular events
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
citation: Ma G, Sun X, Cheng H, Burgin WS, Luo W, Jia W, Liu Y, He W, Geng X, Zhu L, Chen X, Shi H, Xu H, Zhang L, Wang A, Mo D, Ma N, Gao F, Song L, Huo X, Deng Y, Liu L, Luo G, Jia B, Tong X, Liu L, Ren Z, Miao Z; EPOCH Study and ANGEL-ACT Study Groups. Combined Approach to Eptifibatide and Thrombectomy in Acute Ischemic Stroke Because of Large Vessel Occlusion: A Matched-Control Analysis. Stroke. 2022 May;53(5):1580-1588. doi: 10.1161/STROKEAHA.121.036754. Epub 2022 Feb 2.