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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)

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

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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

678,712 Total Patients Enrolled

30 Trials studying Atrial Fibrillation

51,102 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

Edoxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03950076 — Phase 4

Atrial Fibrillation Research Study Groups: Edoxaban 60/30mg daily, Non-anticoagulant medical therapy

Atrial Fibrillation Clinical Trial 2023: Edoxaban Highlights & Side Effects. Trial Name: NCT03950076 — Phase 4

Edoxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950076 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial represent an unprecedented endeavor?

"Currently, 23 clinical trials involving Edoxaban are being conducted across 35 countries and 153 cities. The first study of its kind was funded by Daiichi Sankyo Europe GmbH in 2016 and enrolled 2545 participants to complete Phase 3 drug approval. Since then, a further 60 research studies have been concluded."

Answered by AI

Is the enrollment for this medical trial still open to participants?

"This trial, first posted on September 20th 2019 and recently updated on November 22nd 2021, is currently recruiting participants. Data hosted by clinicaltrials.gov attests to this fact."

Answered by AI

What ailments does Edoxaban have a positive effect in managing?

"Edoxaban is an appropriate pharmaceutical treatment for prophylaxis against systemic embolism, venous thromboembolisms and pulmonary emboli."

Answered by AI

Has Edoxaban previously been tested through other scientific studies?

"Since its initial evaluation in 2016, there have been 60 Edoxaban-focused clinical trials. At present, 23 studies are actively accepting participants and many of these research efforts are located in Montreal and Pennsylvania."

Answered by AI

What purpose does this clinical experiment seek to accomplish?

"The aim of this trial, which is expected to run for a median duration of 2 years, is the reduction of stroke incidence. Secondary objectives include reduced occurrences of Ischemic Stroke (characterised by neurological deficits and brain imaging), Composite Outcome featuring Myocardial Infarction or Systemic Thromboembolism, and Hemorrhagic Stroke (indicated by acute neurologic problems alongside intraparenchymal/intraventricular/subarachnoid hemorrhage)."

Answered by AI

What is the uppermost limit of participants for this experiment?

"Affirmative. The details on clinicaltrials.gov displays that this scientific experiment is actively looking for participants, with the original post created 9/20/2019 and last updated 11/22/2021. A total of 1200 people are needed to be recruited from 28 different research sites."

Answered by AI

Are there any Canadian medical facilities that are currently conducting this research?

"This trial is presently recruiting individuals from 28 medical sites, which includes Montreal, Toronto and Ottawa. When deciding to take part in this study, it is a good idea to pick the closest centre for convenience's sake."

Answered by AI