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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
Study 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death, stroke, systemic embolism or GUSTO outcomes
Secondary outcome measures
Bleeding outcomes
Death, stroke, or systematic embolism or GUSTO outcomes
Death, stroke, or systematic embolism outcomes
+4 moreTrial 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
Edoxaban
FDA approved
Acetylsalicylic acid
FDA approved
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
393 Previous Clinical Trials
416,226 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
64,762 Patients Enrolled for Atrial Fibrillation
Scripps HealthLead Sponsor
55 Previous Clinical Trials
43,386 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
374 Patients Enrolled for Atrial Fibrillation
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
420,083 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
64,996 Patients Enrolled for Atrial Fibrillation
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