Restart TICrH AP Pilot Trial

NCT ID: NCT05000060

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-01

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.

Detailed Description

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Conditions

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Traumatic Intracranial Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Blinded assessment and adjudication of endpoints

Study Groups

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1 week restart

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

Group Type EXPERIMENTAL

Timing/1 week

Intervention Type OTHER

Time of restart of antiplatelet therapy is one week after injury

3 week restart

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

Group Type ACTIVE_COMPARATOR

Timing/3 weeks

Intervention Type OTHER

Time of restart of antiplatelet therapy is left to treating clinician discretion

Interventions

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Timing/1 week

Time of restart of antiplatelet therapy is one week after injury

Intervention Type OTHER

Timing/3 weeks

Time of restart of antiplatelet therapy is left to treating clinician discretion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Truman J Milling Jr

Research Director SDMS Stroke Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Truman J Milling, MD

Role: CONTACT

15124969742

Ashkan J Shoamanesh, MD PhD

Role: CONTACT

Other Identifiers

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UT 101

Identifier Type: -

Identifier Source: org_study_id

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