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Anticoagulant

Edoxaban Arm for Atrial Fibrillation

Phase 4

Waitlist Available

Led By Matthew J Price, MD

Research Sponsored by Scripps Health

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 6 weeks and 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically indicated WATCHMAN left atrial appendage (LAA) closure.

Eligible Conditions

Atrial Fibrillation
Left Atrial Appendage Closure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Death, stroke, systemic embolism or GUSTO outcomes

Secondary study objectives

Bleeding outcomes

Death, stroke, or systematic embolism or GUSTO outcomes

Death, stroke, or systematic embolism outcomes

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

1Treatment groups

Experimental Treatment

Group I: Edoxaban ArmExperimental Treatment4 Interventions

All patients enrolled in the study will receive 6 weeks of edoxaban therapy, at which time a TEE will be performed. If the result is acceptable, edoxaban will be discontinued, and the patient will be treated with dual antiplatelet therapy (aspirin and clopidogrel) until 6 month follow-up. If device thrombus is present at 6 week TEE, patient will be transitioned to aspirin and adjusted-dose warfarin and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference. Subjects will have a 6 month follow-up visit prior to study completion. After study completion, patients may be treated with aspirin monotherapy according to the FDA instructions for use for the WATCHMAN device, or according to operator discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetylsalicylic acid

FDA approved

Edoxaban

FDA approved

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