search
Back to results

Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis

Primary Purpose

Stroke, Brain Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acetylsalicylic acid
Sponsored by
City Clinical Hospital No. 67, Moscow, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring thrombolytic therapy, tissue plasminogen activator, aspirin

Eligibility Criteria

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

Inclusion Criteria:

  • acute ischemic stroke patients treated with rtPA
  • mRS score before current stroke <4
  • NIHSS score after rtPA treatment <25

Exclusion Criteria:

  • contraindications for treatment with aspirin
  • contraindications fot iodinated radiocontrast agents administration
  • intracranial haemorrhage after rtPA treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    12 hours

    24 hours

    Arm Description

    Non-contrast CT and CT-angiography are performed in 11 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 12 hours after thrombolysis

    Non-contrast CT and CT-angiography are performed in 23 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 24 hours after thrombolysis

    Outcomes

    Primary Outcome Measures

    all cause mortality
    ischemic events
    acute myocardial infarction and ischemic stroke
    haemorrhagic events
    intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage

    Secondary Outcome Measures

    functional outcome
    defined by modified Rankin scale
    artery reocclusion
    verified by CT-angiography

    Full Information

    First Posted
    September 12, 2016
    Last Updated
    October 3, 2016
    Sponsor
    City Clinical Hospital No. 67, Moscow, Russia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02921360
    Brief Title
    Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
    Official Title
    Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City Clinical Hospital No. 67, Moscow, Russia

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this study is to determine whether early administration of aspirin in acute ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes due to decreasing the number of early rethromboses.
    Detailed Description
    According to the current guidelines (European Stroke Organisation, 2009; American Heart Association-American Stroke Association, 2013) on the systemic thrombolysis in ischemic stroke patients it is recommended (class C) to start antithrombotic therapy (including antiplatelets and anticoagulants) when 24 hours go after alteplase (rtPA, recombinant tissue plasminogen activator) administration. Meanwhile rtPA has wery short lifetime in blood (T1/2 4-6 minutes). Some retrospective studies have found that early administration of antithrombotics (8-16 hours) after systemic thrombolysis can improve functional outcome and does not increase the risk of haemorrhage. The investigators suggest a controlled prospective trial to recognise risks and benefits of early administration of aspirin (in 12 hours) after rtPA therapy in patients with acute ischemic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Brain Ischemia
    Keywords
    thrombolytic therapy, tissue plasminogen activator, aspirin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    12 hours
    Arm Type
    Experimental
    Arm Description
    Non-contrast CT and CT-angiography are performed in 11 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 12 hours after thrombolysis
    Arm Title
    24 hours
    Arm Type
    No Intervention
    Arm Description
    Non-contrast CT and CT-angiography are performed in 23 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 24 hours after thrombolysis
    Intervention Type
    Drug
    Intervention Name(s)
    acetylsalicylic acid
    Other Intervention Name(s)
    aspirin
    Primary Outcome Measure Information:
    Title
    all cause mortality
    Time Frame
    3 month
    Title
    ischemic events
    Description
    acute myocardial infarction and ischemic stroke
    Time Frame
    3 month
    Title
    haemorrhagic events
    Description
    intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    functional outcome
    Description
    defined by modified Rankin scale
    Time Frame
    3 month
    Title
    artery reocclusion
    Description
    verified by CT-angiography
    Time Frame
    7 days

    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: acute ischemic stroke patients treated with rtPA mRS score before current stroke <4 NIHSS score after rtPA treatment <25 Exclusion Criteria: contraindications for treatment with aspirin contraindications fot iodinated radiocontrast agents administration intracranial haemorrhage after rtPA treatment

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23951093
    Citation
    Amaro S, Llull L, Urra X, Obach V, Cervera A, Chamorro A. Risks and benefits of early antithrombotic therapy after thrombolytic treatment in patients with acute stroke. PLoS One. 2013 Aug 8;8(8):e71132. doi: 10.1371/journal.pone.0071132. eCollection 2013.
    Results Reference
    background

    Learn more about this trial

    Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis

    We'll reach out to this number within 24 hrs