Restart TICrH AP Pilot Trial

Traumatic Intracranial Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05000060
• Other study ID #: UT 101
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2021
• Source: University of Texas at Austin
• Contact: Truman J Milling, MD
• Phone: 15124969742
• Email: tjmilling[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Traumatic Intracranial Hemorrhage

Intervention

Other:
• Timing/1 week
Time of restart of antiplatelet therapy is one week after injury
• Timing/3 weeks
Time of restart of antiplatelet therapy is left to treating clinician discretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major bleeding	Recurrent ICrH or other major bleeding defined by BARC3A	60 days
Primary	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)