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Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke (ATTIS)

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tenecteplase plus Tirofiban
Tenecteplase plus Placebo
Sponsored by
Second Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment within 4.5 hours of stroke onset Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined by the time last observed normal Written informed consent by patient or proxy Exclusion Criteria: Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg Female, pregnant or breast feeding Known bleeding diathesis Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin <48 hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight heparin(oid) <24 hours Any other investigational drug <14 days Sepsis Patients with arterial puncture at a noncompressible site or lumbar puncture <7 days Major surgery or serious trauma <14 days Gastrointestinal or urinary tract hemorrhage <14 days Clinical stroke <2 months History of intracranial haemorrhage Brain neurosurgery <2 months Serious head trauma <2 months Pericarditis Any serious medical illness likely to interact with treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete follow-up Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tenecteplase plus Tirofiban

    Tenecteplase plus Placebo

    Arm Description

    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .

    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .

    Outcomes

    Primary Outcome Measures

    functional independence
    mRS score, 0-2
    mortality
    mRS score, 6

    Secondary Outcome Measures

    excellent functional outcome
    mRS score, 0-1
    symptomatic intracranial hemorrhage
    any intracranial hemorrhage

    Full Information

    First Posted
    October 28, 2022
    Last Updated
    November 2, 2022
    Sponsor
    Second Affiliated Hospital of Guangxi Medical University
    Collaborators
    CSPC Pharmaceutical Group Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05604638
    Brief Title
    Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
    Acronym
    ATTIS
    Official Title
    Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital of Guangxi Medical University
    Collaborators
    CSPC Pharmaceutical Group Limited

    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 assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
    Detailed Description
    Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tenecteplase plus Tirofiban
    Arm Type
    Experimental
    Arm Description
    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .
    Arm Title
    Tenecteplase plus Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds). Patients will receive a continuous intravenous infusion of placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .
    Intervention Type
    Drug
    Intervention Name(s)
    Tenecteplase plus Tirofiban
    Intervention Description
    Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min
    Intervention Type
    Drug
    Intervention Name(s)
    Tenecteplase plus Placebo
    Intervention Description
    Patients will receive a continuous intravenous infusion of Placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min
    Primary Outcome Measure Information:
    Title
    functional independence
    Description
    mRS score, 0-2
    Time Frame
    90 days
    Title
    mortality
    Description
    mRS score, 6
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    excellent functional outcome
    Description
    mRS score, 0-1
    Time Frame
    90 days
    Title
    symptomatic intracranial hemorrhage
    Time Frame
    48 hours
    Title
    any intracranial hemorrhage
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment within 4.5 hours of stroke onset Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined by the time last observed normal Written informed consent by patient or proxy Exclusion Criteria: Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg Female, pregnant or breast feeding Known bleeding diathesis Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin <48 hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight heparin(oid) <24 hours Any other investigational drug <14 days Sepsis Patients with arterial puncture at a noncompressible site or lumbar puncture <7 days Major surgery or serious trauma <14 days Gastrointestinal or urinary tract hemorrhage <14 days Clinical stroke <2 months History of intracranial haemorrhage Brain neurosurgery <2 months Serious head trauma <2 months Pericarditis Any serious medical illness likely to interact with treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete follow-up Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shengliang Shi, MD
    Phone
    +8613707888628
    Email
    ssl_1964@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Deyan Kong, MD
    Phone
    +8618376635080
    Email
    kongdeyangxnn@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

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