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Anticoagulant

Timing of Anticoagulation After Intracranial Hemorrhage (Restart tICrH Trial)

Phase 3

Waitlist Available

Led By Truman J Milling, MD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE) or both (2,500 patients per year at our 40 sites)

Be older than 18 years old

Must not have

Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4

Any active pathological bleeding (e.g. no acute blood on most recent CT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days following index bleeding event

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether it is better to restart oral anticoagulation a week after a traumatic brain bleed, or 2 or 4 weeks later. The primary outcome is a composite of thromboembolic events (DVT, pulmonary emboli, etc) and bleeding events.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include increased risk of new bleeds in the brain or elsewhere in the body if anticoagulation therapy is restarted too soon, as well as possible clotting events like strokes or heart attacks if therapy is delayed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any current bleeding issues.

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My kidney function is not too low for blood thinner use.

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I understand the importance of following the study's rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days following index bleeding event

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days following index bleeding event

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days following index bleeding event for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

60 Day Composite of Thrombotic and Bleeding Events

Secondary study objectives

60 Day Disability Rating Scale (1-29 with 29 being worse)

60 Day Modified Rankin Scale (1-6 with 6 being worse)

Standard Gamble Patient Reported utilities for endpoints

Side effects data

From 2018 Phase 4 trial • 206 Patients • NCT02984982

15%

Nasopharyngitis

Myocardial ischaemia

Pneumonia

Acute myocardial infarction

Myocardial infarction

Prinzmetal angina

Ventricular tachycardia

Transient ischaemic attack

Rectal cancer

Cardiac failure

Acute coronary syndrome

Angina unstable

Vascular pseudoaneurysm

Haemorrhoids

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Standard of Care

Alirocumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anticoagulants

2016

Completed Phase 4

~810

0 / 5Eligibility criteria met