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
About this trial
This is an interventional prevention trial for Traumatic Intracranial Hemorrhage focused on measuring restart, antiplatelet, traumatic intracranial hemorrhage
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
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
NCT ID
NCT05000060
First Posted
July 26, 2021
Last Updated
September 29, 2021
Sponsor
University of Texas at Austin
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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Restart TICrH AP Pilot Trial
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