NCT03844594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 6, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

February 14, 2019

Last Update Submit

June 16, 2019

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic StrokeEptifibatideEndovascular TreatmentRecovery of Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Symptomatic intracranial hemorrhage

    Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment

    Within 48 hours

Secondary Outcomes (12)

  • Cerebral parenchymal hemorrhage type (PH1) and (PH2)

    48 hours

  • Serious adverse events

    Within 48 hours

  • Total death rate

    Within 48 hours

  • Adverse events

    Within 48 hours

  • Serious adverse events

    Within 90 days

  • +7 more secondary outcomes

Study Arms (1)

Eptifibatide Drug: Eptifibatide Injection

EXPERIMENTAL
Drug: Eptifibatide Injection

Interventions

Eptifibatide InjectionDRUG

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.

Eptifibatide Drug: Eptifibatide Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35105182DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Zhongrong Miao, PHD,MD

CONTACT

0086-10-59975211zhongrongm@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Neurological Intervention

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

April 6, 2019

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

CN(1)