Restart TICrH Alpha Pilot Protocol, Restarting DOACs After Traumatic Intracranial Hemorrhage

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

NCT00363753

Transient Ischemic Attack Stroke Aspirin +1 more

WITHDRAWN PHASE1

Platelet Function in Patients With Ischemic Stroke Treated With Anti-thrombotic or Thrombolytic

NCT05415150

Acute Ischemic Stroke

UNKNOWN PHASE1/PHASE2

Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma

NCT05472766

Subdural Hematoma Atrial Fibrillation

TERMINATED NA

Safety of Intravenous Thrombolysis for Wake-up Stroke

NCT01183533

Ischemic Stroke

COMPLETED PHASE2

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

NCT03661528

Acute Intracranial Hemorrhage

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Restart TICrH two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. Entry into the trial is primarily driven pragmatically by clinician intent to restart any Direct Oral Anticoagulant (DOAC, i.e. apixaban, rivaroxaban, edoxaban, dabigatran. There is no head to head evidence of superiority of any drug) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anticoagulants; Increased

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial of 1 versus 4 week DOAC restart after TICrH

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Central blinded assessment of endpoints

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 week restart

restart DOAC at 1 week post injury at label dose and frequency

Group Type ACTIVE_COMPARATOR

Apixaban

Intervention Type DRUG

Direct Oral Anticoagulation all at label dose and frequency

4 week restart

restart DOAC at 4 weeks post injury at label dose and frequency

Group Type ACTIVE_COMPARATOR

Apixaban

Intervention Type DRUG

Direct Oral Anticoagulation all at label dose and frequency

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apixaban

Direct Oral Anticoagulation all at label dose and frequency

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rivaroxaban Edoxaban Dabigatran

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE)
2. Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of \> 3 (at least 3 of the following risk factors: age greater than 65, (age \> 75 counts for 2 points), history of stroke or TIA (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension)
3. DOAC prescribed at label dose with creatinine clearance adjustments. DOAC at continuation dose, i.e., not initial therapy high doses in the setting of VTE

Exclusion Criteria

1. Mechanical Valve or Ventricular Assist Device (VAD)
2. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
3. Physician plan to start/restart antiplatelet therapy during trial period
4. Abbreviated Injury Scale other than head \>3
5. Pregnancy
6. Inability to understand need for adherence to study protocol
7. Renal function below DOAC label exclusions
8. Any active pathological bleeding (e.g. no acute blood on most recent CT)
9. Hypersensitivity to drug or other label contraindication
10. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
11. Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment
12. Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
13. Low body weight (\<45kg)
14. Inability to swallow

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No