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Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tirofiban
Tirofiban simulant
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, intravenous thrombolysis, tirofiban

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years old; Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset; Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT; Tirofiban or placebo treatment can be initiated within 6h after IVT; mRS score before onset≤ 1; Intracranial hemorrhage is ruled out by CT head after IVT; Systolic blood pressure before enrollment≤ 160mmHg; Exclusion Criteria: Received or plan to undergo bridge therapy; Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area); Atrial fibrillation or suspected cardiac embolism; Accompanied by epileptic seizures; Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment; Active bleeding or tendency to bleed after receipt of intravenous thrombolysis; Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year; Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L; Life expectancy less than 3 months; Pregnant or lactating women; Known allergy to tirofiban; Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.; Patients who are unwilling to be followed up or likely to have poor treatment compliance; Other situations that the researcher deems unsuitable for inclusion in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Tirofiban group

    Tirofiban simulant group

    Arm Description

    Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT

    Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT

    Outcomes

    Primary Outcome Measures

    Proportion of patients of modified Rankin Scale (mRS)≤1
    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome

    Secondary Outcome Measures

    Proportion of patients of mRS≤2
    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome
    Distribution of mRS
    mRS depicts functional outcome of stroke, which ranges from 0-6
    National Institute of Health stroke scale (NIHSS)
    National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 19, 2023
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045156
    Brief Title
    Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke
    Official Title
    Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 30, 2026 (Anticipated)
    Study Completion Date
    December 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
    Detailed Description
    Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size. Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke
    Keywords
    acute ischemic stroke, intravenous thrombolysis, tirofiban

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1084 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tirofiban group
    Arm Type
    Active Comparator
    Arm Description
    Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT
    Arm Title
    Tirofiban simulant group
    Arm Type
    Placebo Comparator
    Arm Description
    Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT
    Intervention Type
    Drug
    Intervention Name(s)
    Tirofiban
    Intervention Description
    Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation
    Intervention Type
    Drug
    Intervention Name(s)
    Tirofiban simulant
    Intervention Description
    Tirofiban simulant is placebo packed the same style as tirofiban
    Primary Outcome Measure Information:
    Title
    Proportion of patients of modified Rankin Scale (mRS)≤1
    Description
    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome
    Time Frame
    90±7 days
    Secondary Outcome Measure Information:
    Title
    Proportion of patients of mRS≤2
    Description
    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome
    Time Frame
    90±7 days
    Title
    Distribution of mRS
    Description
    mRS depicts functional outcome of stroke, which ranges from 0-6
    Time Frame
    90±7 days
    Title
    National Institute of Health stroke scale (NIHSS)
    Description
    National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome
    Time Frame
    24 hours after IVT, 7 days
    Other Pre-specified Outcome Measures:
    Title
    Symptomatic intracranial hemorrhage
    Description
    Symptomatic intracranial hemorrhage is defined according to the ECASS Classification
    Time Frame
    within 24 hours of completion of study drug infusion, hospitalization
    Title
    Hemorrhagic transformation
    Description
    defined according to the ECASS Classification
    Time Frame
    24 hours after IVT, hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥18 years old; Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset; Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT; Tirofiban or placebo treatment can be initiated within 6h after IVT; mRS score before onset≤ 1; Intracranial hemorrhage is ruled out by CT head after IVT; Systolic blood pressure before enrollment≤ 160mmHg; Exclusion Criteria: Received or plan to undergo bridge therapy; Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area); Atrial fibrillation or suspected cardiac embolism; Accompanied by epileptic seizures; Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment; Active bleeding or tendency to bleed after receipt of intravenous thrombolysis; Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year; Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L; Life expectancy less than 3 months; Pregnant or lactating women; Known allergy to tirofiban; Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.; Patients who are unwilling to be followed up or likely to have poor treatment compliance; Other situations that the researcher deems unsuitable for inclusion in the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

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