Clinical trial NCT03088072: A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
Official title: A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Valvular Atrial Fibrillation
Left Atrial Appendage Closure
Keywords: Edoxaban
WATCHMAN device
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2017-03-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a single site, PI initiated pilot study. This study will enroll up to 75 patients who are clinically indicated for a Left Atrial Appendage (LAA) closure with the commercially available WATCHMAN device. Subjects will be enrolled if they meet study inclusion/exclusion criteria and have a successful LAA closure. All patients enrolled in the study will receive 6 weeks of edoxaban therapy. At 6 weeks post LAA closure a Transesophageal Echocardiography (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. 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.

Eligibility criteria: Inclusion Criteria:

* The patient has documented paroxysmal, persistent, or permanent non-valvular AF (i.e., the patient has not been diagnosed with rheumatic mitral valve disease).
* LAA closure with the WATCHMAN device is planned
* The patient fulfills the FDA indication for WATCHMAN LAA closure
* The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
* The patient is able and willing to return for required follow-up visits and examinations.
* The patient is 18 years of age or older

Exclusion Criteria:

* Conditions other than atrial fibrillation that require anti-coagulation (e.g., a prosthetic heart valve)
* Stroke within the previous 7 days
* Hypersensitivity to edoxaban
* Moderate or severe mitral stenosis
* A need for aspirin at a dose of \>81 mg a day
* A need for on-going treatment with dual antiplatelet therapy with aspirin and clopidogrel
* A need for on-going treatment with ticagrelor or prasugrel
* No LAA closure device implanted during procedure
* Procedural complication of LAA closure (e.g., stroke, systemic embolism, bleeding, vascular complication \[e.g., groin hematoma \>10cm, AV fistula, or pseudoaneurysm), or serious pericardial effusion)
* Planned surgery or invasive procedure within 6±2 weeks of enrollment

Primary outcomes:
measure: Death, stroke, systemic embolism or GUSTO outcomes
timeFrame: 6 weeks
Secondary outcomes:
measure: Death, stroke, or systematic embolism outcomes
timeFrame: 6 weeks and 6 months
measure: Death, stroke, or systematic embolism or GUSTO outcomes
timeFrame: 6 months
measure: Device thrombus oucomes
timeFrame: 6 weeks
measure: TEE peri-device flow outcomes
timeFrame: 6 weeks
measure: GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding outcomes
timeFrame: 6 weeks and 6 months
measure: Premature discontinuation rate of study drug
timeFrame: 6 weeks
measure: Bleeding outcomes
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Health
name: Matthew J Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
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