Recruiting

Edoxaban

Sponsor:

Scripps Health

Code:

NCT03088072

Conditions

Non-Valvular Atrial Fibrillation

Left Atrial Appendage Closure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Edoxaban

WATCHMAN LAA Closure

Aspirin and Clopidogrel

Aspirin and Warfarin

Study Details

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.

Conditions

Non-Valvular Atrial Fibrillation

Left Atrial Appendage Closure

Study ID

NCT03088072

Start date

Mar 23, 2017

Status verified date

Jul, 2017

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Nov 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Edoxaban Arm

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.

Interventions

Edoxaban

Edoxaban 60mg once daily in patients with CrCl >50- ≤95 mL/min, or 30mg once daily in patients with CrCL 15-50 mL/min.

If at 6 week TEE LAA closure is deemed acceptable by the operator (i.e., peri-device flow <5mm), edoxaban will be discontinued. Aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up, then clopidogrel will be discontinued.

If LAA unacceptable on 6-week TEE due to peri-device flow ≥5mm, edoxaban will be continued for an additional 6 weeks, and LAA reassessed by TEE If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference.

WATCHMAN LAA Closure

Per Inclusion Criteria, enrolled subjects must have a successful Left Atrial Appendage (LAA) Closure using the WATCHMAN Device

Aspirin and Clopidogrel

If at 6 week TEE LAA closure is deemed acceptable by the operator edoxaban will be discontinued, and aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up. Then clopidogrel will be discontinued.

Aspirin 325mg daily rather than 81mg daily can be administered according to operator preference after the 6-week follow-up visit.

Aspirin and Warfarin

If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference.

Primary outcome measure

  • Death, stroke, systemic embolism or GUSTO outcomes [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Catchpole Heather

858 824 4248Catchpole.Heather@scrippshealth.org

Locations

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Heather Catchpole

858-824-4248Catchpole.Heather@scrippshealth.org

More Information

Sponsor

Scripps Health

Last update posted

Jul 11, 2017

Last verified

Jul, 2017

Keywords

  • Edoxaban
  • WATCHMAN device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2017-07-11.