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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days following index bleeding event
Awards & highlights
Restart tICrH 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.Check my eligibility
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.See study design
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.
Restart tICrH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a recent brain bleed while on blood thinners for AF or VTE.
Restart tICrH Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
60 Day Composite of Thrombotic and Bleeding Events
Secondary outcome measures
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 • NCT0298498215%
Nasopharyngitis
3%
Myocardial ischaemia
2%
Myocardial infarction
2%
Acute myocardial infarction
2%
Pneumonia
1%
Acute coronary syndrome
1%
Vascular pseudoaneurysm
1%
Rectal cancer
1%
Cardiac failure
1%
Prinzmetal angina
1%
Transient ischaemic attack
1%
Angina unstable
1%
Ventricular tachycardia
1%
Sepsis
1%
Haemorrhoids
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Alirocumab
Restart tICrH 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
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
79,884 Total Patients Enrolled
Truman J Milling, MDPrincipal InvestigatorSeton Dell Medical School Stroke Institute
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am at high risk for stroke with a CHA2DS2-VASc score over 3.You are allergic to the drug or have a specific reason not to take it according to the label.I have a recent brain bleed while on blood thinners for AF or VTE.You have a subdural hematoma larger than 8 millimeters wide or any shifting of the brain's midline, or more than one subdural hematoma.My doctor plans to restart my blood thinner medication after a brain bleed.I do not have any current bleeding issues.My kidney function is not too low for blood thinner use.I understand the importance of following the study's rules.My doctor plans to begin or resume antiplatelet therapy while I'm in the trial.You have a severe injury score of 3 or higher, not including head injuries.You have a mechanical heart valve.I will finish my blood thinner treatment before 60 days.You have a ventricular assist device (VAD).
Research Study Groups:
This trial has the following groups:- Group 1: 1 week
- Group 2: 2 weeks
- Group 3: 4 weeks
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling for this clinical trial?
"Although no longer actively recruiting patients, this clinical trial was posted on October 1st 2021 and last updated May 14th 2021. Currently, there are 460 other trials that are still enrolling individuals."
Answered by AI
Anticoagulants: how risky are they for patients?
"Anticoagulants have been studied in multiple Phase 3 trials, so they have received a score of 3 for safety."
Answered by AI
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