What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation, particularly anticoagulants like Edoxaban, which inhibit Factor Xa to reduce clot formation, have several known side effects. These include an increased risk of bleeding, which can range from minor bruising to major bleeding events such as gastrointestinal bleeding or intracranial hemorrhage. Other side effects may include gastrointestinal issues like dyspepsia and, less commonly, liver enzyme abnormalities. Compared to warfarin, Edoxaban and other direct oral anticoagulants (DOACs) like rivaroxaban and apixaban generally have a more predictable pharmacokinetic profile, which can reduce the need for frequent monitoring but still carry a significant bleeding risk.

What prior FDA approvals exist?

Several anticoagulants have been approved by the FDA for the treatment of Atrial Fibrillation, particularly those that inhibit Factor Xa to reduce clot formation. These include Edoxaban, Rivaroxaban, and Apixaban. Edoxaban, like the other Factor Xa inhibitors, works by blocking the activity of Factor Xa, an essential component in the blood clotting process, thereby reducing the risk of stroke and systemic embolism in patients with non-valvular AF. These drugs offer an alternative to traditional vitamin K antagonists like warfarin, providing similar efficacy with a more predictable pharmacological profile and fewer dietary restrictions.

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Anticoagulant

Edoxaban for Atrial Fibrillation (ENRICH-AF Trial)

Q: What other types of research exist?

Promising alternatives to Edoxaban for AF patients include other direct oral anticoagulants (DOACs) such as Rivaroxaban, Apixaban, and Dabigatran. These agents have been shown to be effective in reducing the risk of stroke and systemic embolism in AF patients. Additionally, novel agents like Betrixaban and Andexanet alfa (a reversal agent for Factor Xa inhibitors) are also being explored for their potential benefits in anticoagulation therapy.

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if edoxaban, a daily blood-thinning medication, can safely reduce stroke risk in high-risk atrial fibrillation patients who have had previous brain bleeds. The goal is to see if it works better than not using any blood thinners or using simpler treatments. Edoxaban has been shown to be effective in preventing stroke with a lower risk of bleeding.

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.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the common study end date (median 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Major hemorrhage

Stroke

Secondary study objectives

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 more

Side effects data

From 2016 Phase 3 trial • 2199 Patients • NCT02072434

Atrial fibrillation

International normalised ratio increased

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Warfarin

Edoxaban

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

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

Do I qualify?Apply below to find out

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.