Restart TICrH AP Pilot Trial

A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.

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 Overview

• Status: Not yet recruiting
• Conditions: Traumatic Intracranial Hemorrhage
• Intervention / Treatment: Other: Timing/1 week; Other: Timing/3 weeks

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Truman J Milling, MD; Phone Number: 15124969742; Email: tjmilling@yahoo.com
• Study Contact Backup: Name: Ashkan J Shoamanesh, MD PhD; Email: ashkan.shoamanesh@phri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 week restart; Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients	Other: Timing/1 week; Time of restart of antiplatelet therapy is one week after injury
Active Comparator: 3 week restart; Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion	Other: Timing/3 weeks; Time of restart of antiplatelet therapy is left to treating clinician discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: antiplatelet; restart; traumatic intracranial hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Hemorrhage; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic
• Other Study ID Numbers: UT 101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing with NIH BIOLINCC
• IPD Sharing Time Frame: 2 years from study launch
• IPD Sharing Access Criteria: per NIH policy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No