Restart TICrH AP Pilot Trial

NCT05000060 | Unknown Phase 3

• 1 other identifier: UT 101
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Intracranial Hemorrhage

Keywords

restart; antiplatelet; traumatic intracranial hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

1 week restart

EXPERIMENTAL

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

Other: Timing/1 week

3 week restart

ACTIVE COMPARATOR

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

Other: Timing/3 weeks

Interventions

Timing/1 week OTHER

Time of restart of antiplatelet therapy is one week after injury

1 week restart

Timing/3 weeks OTHER

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

3 week restart

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Central Study Contacts

Truman J Milling, MD

CONTACT

15124969742; tjmilling@yahoo.com

Ashkan J Shoamanesh, MD PhD

CONTACT

ashkan.shoamanesh@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment and adjudication of endpoints
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director SDMS Stroke Institute

Model Details: Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 11, 2021
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years from study launch
• Access Criteria: per NIH policy