A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 100
- Primary Endpoint
- Major Vascular Occlusive events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinded assessment and adjudication of endpoints
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
1 week restart
Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients
Intervention: Timing/1 week (Other)
3 week restart
Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion
Intervention: Timing/3 weeks (Other)
Outcomes
Primary Outcomes
Major Vascular Occlusive events
Time Frame: Baseline (gambles performed pre-randomization)
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
major bleeding
Time Frame: 60 days
Recurrent ICrH or other major bleeding defined by BARC3A
Secondary Outcomes
No secondary outcomes reported
Investigators
Truman J Milling Jr
Research Director SDMS Stroke Institute
University of Texas at Austin