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Anticoagulant
Edoxaban for Atrial Fibrillation (ENRICH-AF Trial)
Phase 4
Recruiting
Led By Ashkan Shoamanesh, MD. FRCPC
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the common study end date (median 2 years)
Awards & highlights
ENRICH-AF Trial Summary
This trial is testing whether a new blood thinner reduces the risk of stroke in people with a history of brain bleed.
Who is the study for?
This trial is for adults over 45 who've had a non-traumatic brain bleed, have atrial fibrillation with a CHA2DS2-VASc score of at least 2, and are stable. It's not for those with bleeding risks like ulcers, clotting disorders, liver disease, or sensitivity to edoxaban. Pregnant women and those unlikely to follow the study plan are also excluded.Check my eligibility
What is being tested?
The ENRICH-AF trial is testing if edoxaban (a blood thinner) is better than standard care without anticoagulants in preventing strokes in patients with atrial fibrillation who previously had a brain hemorrhage.See study design
What are the potential side effects?
Edoxaban may increase the risk of bleeding including gastrointestinal bleeds. Other side effects can include allergic reactions to the medication and potential interactions that could affect how it works.
ENRICH-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the common study end date (median 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the common study end date (median 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major hemorrhage
Stroke
Secondary outcome measures
All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
Cardiovascular death
Composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death
+8 moreSide effects data
From 2016 Phase 3 trial • 2199 Patients • NCT020724345%
Atrial fibrillation
1%
International normalised ratio increased
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Warfarin
Edoxaban
ENRICH-AF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Edoxaban 60/30mg dailyExperimental Treatment1 Intervention
Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Group II: Non-anticoagulant medical therapyActive Control1 Intervention
Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edoxaban
2020
Completed Phase 4
~181430
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atrial Fibrillation include anticoagulants, rate control medications, and rhythm control medications. Anticoagulants, such as Edoxaban, work by inhibiting Factor Xa, which is crucial in the blood clotting process, thereby reducing the risk of stroke and systemic embolism in AF patients.
Rate control medications, like beta-blockers and calcium channel blockers, slow the heart rate, improving symptoms and preventing tachycardia-induced cardiomyopathy. Rhythm control medications, such as amiodarone, help maintain normal sinus rhythm.
These treatments are vital as they address the primary risks associated with AF: stroke, heart failure, and reduced quality of life.
Find a Location
Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
156 Previous Clinical Trials
679,932 Total Patients Enrolled
31 Trials studying Atrial Fibrillation
52,322 Patients Enrolled for Atrial Fibrillation
Ashkan Shoamanesh, MD. FRCPCPrincipal InvestigatorPopulation Health Research Institute
Ashkan Shoamanesh, MD, FRCPCPrincipal InvestigatorPopulation Health Research Institute
1 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
2,000 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a brain bleed in the last 14 days.My brain bleed isn't due to cancer, infection, or major blood vessel issues.I am currently experiencing significant bleeding.My blood pressure is often higher than 150 mmHg.I have been diagnosed with antiphospholipid antibody syndrome.I have had a specific type of bleeding in my brain.I have been diagnosed with atrial fibrillation.I have had a stroke caused by bleeding in the brain.I have had a brain bleed in the past.I am a woman not currently able to have children, confirmed by tests or surgery.I need to continue taking blood thinner medication that cannot be replaced by edoxaban.My platelet count is below 100,000 or I have a bleeding disorder.I am planning to undergo a procedure to close off the left atrial appendage.My kidney function is severely reduced.I need daily blood thinner medication for a condition other than atrial fibrillation.I am 45 years old or older.I regularly use anti-inflammatory medication.I have liver disease that increases my risk of bleeding.I have a condition that increases my risk of serious bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Edoxaban 60/30mg daily
- Group 2: Non-anticoagulant medical therapy
Awards:
This trial has 3 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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