Restart TICrH AP Pilot Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.

Conditions
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Traumatic Intracranial Hemorrhage

Intervention / Treatment
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* Other: Timing/1 week
* Other: Timing/3 weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 week restart<br>Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients | Other: Timing/1 week<br>* Time of restart of antiplatelet therapy is one week after injury<br>|
| Active Comparator: 3 week restart<br>Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion | Other: Timing/3 weeks<br>* Time of restart of antiplatelet therapy is left to treating clinician discretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleeding | Recurrent ICrH or other major bleeding defined by BARC3A | 60 days | 
| 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 | Baseline (gambles performed pre-randomization) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restart, antiplatelet, traumatic intracranial hemorrhage