Restart TICrH AP Pilot Trial

Phase 3

• Conditions: Traumatic Intracranial Hemorrhage
• Interventions: Other: Timing/1 week; Other: Timing/3 weeks

• Registration Number: NCT05000060
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 week restart	Timing/1 week	Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients
3 week restart	Timing/3 weeks	Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion

Primary Outcome Measures

Name	Time	Method
Major Vascular Occlusive events	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	60 days	Recurrent ICrH or other major bleeding defined by BARC3A