Restart TICrH AP Pilot Trial

The University of Texas System (UT)

Status and phase: Unknown; Phase 3

Conditions: Traumatic Intracranial Hemorrhage

Treatments: Other: Timing/3 weeks; Other: Timing/1 week

Study type: Interventional

Funder types: Other

Identifiers

NCT05000060

UT 101

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

1 week restart

Experimental group

Description:

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

Treatment:

Other: Timing/1 week

3 week restart

Active Comparator group

Description:

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

Treatment:

Other: Timing/3 weeks