Apply to Trial

Compensation: Varies

Number of Visits: 64

Duration: 4 weeks

1100 Participants Needed

Timing of Anticoagulation After Intracranial Hemorrhage
(Restart tICrH Trial)

Overseen ByPatrick Lawrence

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas at Austin

Must be taking: Direct oral anticoagulants

Must not be taking: Antiplatelet therapy

Disqualifiers: Mechanical valve, Pregnancy, Renal function, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it focuses on restarting anticoagulation after a brain bleed. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of anticoagulant drugs after intracranial hemorrhage?

The research indicates that starting anticoagulant drugs early after brain surgery can be done safely, but there is a risk of bleeding in the brain. In a study, only one out of eighteen patients experienced significant bleeding after starting anticoagulants, suggesting that while there is a risk, it is relatively low.¹ ² ³ ⁴ ⁵

Is anticoagulant therapy generally safe for humans?

Anticoagulant therapy, including drugs like warfarin and direct oral anticoagulants (DOACs), can lead to serious bleeding complications, especially in the brain, with high mortality rates reported in some studies. However, the safety of these treatments can vary depending on the condition being treated and the patient's overall health, and more research is needed to fully understand the risks.¹ ⁶ ⁷ ⁸ ⁹

How is the drug anticoagulants used after intracranial hemorrhage different from other treatments?

Anticoagulants are unique because they are used to prevent blood clots, but their use after an intracranial hemorrhage (bleeding in the brain) is complex due to the risk of further bleeding. The timing of when to restart these drugs after such an event is crucial and varies, as there is no standard guideline, making it a challenging decision for doctors.¹ ³ ⁵ ¹⁰ ¹¹

What is the purpose of this trial?

Primary Objective:To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding.Primary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH).Secondary objectives of this trial include:1. To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop.2. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks.3. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity.4. To explore the composite without DVT in the thrombotic component

Research Team

Truman J Milling, MD

Principal Investigator

Seton Dell Medical School Stroke Institute

Eligibility Criteria

This trial is for patients who've had a traumatic brain bleed while on blood thinners for atrial fibrillation or clot prevention. They should be at high risk of stroke, with specific criteria met (CHA2DS2-VASc score >3), and their doctors are considering restarting anticoagulants within 1 to 4 weeks after the bleeding event.

Inclusion Criteria

I am at high risk for stroke with a CHA2DS2-VASc score over 3.

I have a recent brain bleed while on blood thinners for AF or VTE.

My doctor plans to restart my blood thinner medication after a brain bleed.

Exclusion Criteria

If you have bleeding that your doctor thinks is not safe to start or stop a specific medication after a week or four weeks.

I am not taking medication that strongly affects certain liver enzymes.

You are allergic to the drug or have a specific reason not to take it according to the label.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to restart anticoagulation at 1 week, 2 weeks, or 4 weeks following injury

4 weeks

Weekly visits for 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Weekly visits for 60 days

Treatment Details

Interventions

Anticoagulants

Trial Overview The study tests when it's best to restart blood thinners (DOACs) after a brain bleed due to injury: at 1 week, 2 weeks, or 4 weeks. The goal is to balance preventing clots against the risk of more bleeding. It uses random assignment and looks at thrombotic and bleeding events over two months.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: 4 weeksExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.

Group II: 2 weeksExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.

Group III: 1 weekExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.