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Restart TICrH AP Pilot Trial

Primary Purpose

Traumatic Intracranial Hemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Timing/1 week
Timing/3 weeks
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Traumatic Intracranial Hemorrhage focused on measuring restart, antiplatelet, traumatic intracranial hemorrhage

Eligibility Criteria

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

Inclusion Criteria:

  1. Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy
  2. History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet *Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).

Exclusion Criteria:

  1. SDH >8 mm maximum width or any midline shift at any time point or more than one SDH
  2. Physician plan to start/restart anticoagulant therapy during trial period
  3. Abbreviated Injury Scale other than head >3
  4. Pregnancy
  5. Inability to understand need for adherence to study protocol
  6. Any active pathological bleeding (no acute blood on most recent CT)
  7. Hypersensitivity to drug or other label contraindication
  8. Any bleeding that the investigator deems unsafe to restart at 1 week post injury
  9. Inability to swallow

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1 week restart

    3 week restart

    Arm Description

    Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients

    Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion

    Outcomes

    Primary Outcome Measures

    major bleeding
    Recurrent ICrH or other major bleeding defined by BARC3A
    Major Vascular Occlusive events
    Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2021
    Last Updated
    September 29, 2021
    Sponsor
    University of Texas at Austin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05000060
    Brief Title
    Restart TICrH AP Pilot Trial
    Official Title
    A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas at Austin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Intracranial Hemorrhage
    Keywords
    restart, antiplatelet, traumatic intracranial hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
    Masking
    Outcomes Assessor
    Masking Description
    Blinded assessment and adjudication of endpoints
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1 week restart
    Arm Type
    Experimental
    Arm Description
    Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients
    Arm Title
    3 week restart
    Arm Type
    Active Comparator
    Arm Description
    Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion
    Intervention Type
    Other
    Intervention Name(s)
    Timing/1 week
    Intervention Description
    Time of restart of antiplatelet therapy is one week after injury
    Intervention Type
    Other
    Intervention Name(s)
    Timing/3 weeks
    Intervention Description
    Time of restart of antiplatelet therapy is left to treating clinician discretion
    Primary Outcome Measure Information:
    Title
    major bleeding
    Description
    Recurrent ICrH or other major bleeding defined by BARC3A
    Time Frame
    60 days
    Title
    Major Vascular Occlusive events
    Description
    Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration
    Time Frame
    Baseline (gambles performed pre-randomization)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet *Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement). Exclusion Criteria: SDH >8 mm maximum width or any midline shift at any time point or more than one SDH Physician plan to start/restart anticoagulant therapy during trial period Abbreviated Injury Scale other than head >3 Pregnancy Inability to understand need for adherence to study protocol Any active pathological bleeding (no acute blood on most recent CT) Hypersensitivity to drug or other label contraindication Any bleeding that the investigator deems unsafe to restart at 1 week post injury Inability to swallow
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Truman J Milling, MD
    Phone
    15124969742
    Email
    tjmilling@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashkan J Shoamanesh, MD PhD
    Email
    ashkan.shoamanesh@phri.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data sharing with NIH BIOLINCC
    IPD Sharing Time Frame
    2 years from study launch
    IPD Sharing Access Criteria
    per NIH policy
    IPD Sharing URL
    https://biolincc.nhlbi.nih.gov/home/

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