Clinical trial NCT05540587: Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Official title: A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mitral Valve Stenosis
Atrial Fibrillation
Stroke
Systemic Embolism
Keywords: Edoxaban
Warfarin
Stroke
Systemic embolism
Mitral Valve Stenosis
Atrial Fibrillation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Korea Co., Ltd.
First posted: 2022-09-14
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis.

The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outcome was major bleeding.

Detailed description: Non-vitamin K antagonist oral anticoagulants (NOACs) are generally recommended as 1st line therapy for oral anticoagulant in patients with atrial fibrillation (AF). But, the efficacy and safety of NOAC in AF patients with prosthetic mechanical heart valves or moderate to severe mitral valve stenosis have not been proven, and the guidelines recommend vitamin K antagonist (VKA) administration to those patient groups. This trial aims to compare the efficacy and safety of the edoxaban and the warfarin in AF patients with moderate to severe mitral valve stenosis.

Edoxaban in patients with aTrial fibrillation and MItral Stenosis (ERTEMIS) trial is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. The primary efficacy outcome is a composite of stroke and systemic arterial thromboembolism. The secondary efficacy outcomes are each component of the primary efficacy outcomes and death from any cause. The safety outcome was major bleeding.

Eligibility criteria: * Inclusion criteria

  * 18 \< Age \< 80
  * AF diagnosed by ECG at any time prior to enrollment
  * Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time prior to enrollment
* Exclusion criteria

  * Refusal to consent
  * Transient AF due to reversible cause (Postoperative, ongoing systemic inflammation, thyrotoxicosis)
  * Patients undergoing mechanical valve replacement
  * Coagulopathy
  * Hepatic impairment with significant bleeding risk
  * High bleeding risk due to following disease or condition diagnosed within 1 month prior to randomization

    * GI ulcer or bleeding, Esophageal or gastric varix, Malignancy, Brain or cord injury, Surgery for brain, spinal cord, opthalmic, Intracranial hemorrhage, Arteriovenous malformation, Vascular aneurysms, Brain or spinal vascular disorder
  * Stroke, Systemic arterial thromboembolism, Acute myocardial infarction diagnosed within 14 days prior to randomization
  * End stage kidney disease (CrCL \< 15mL/min) or Dialysis
  * Severe hypertension
  * Alcohol abuse or other psychiatric disease
  * Epidural puncture or anesthesia
  * Pulmonary thromboembolism with hemodynamical instability requiring thrombolysis or thrombectomy
  * Pregnant or lactating women
  * Allergy to edoxaban or warfarin
  * Ongoing need for other anticoagulant or clarithromycin, rifampin)
  * Participants for other trials within 1 month prior to enrollment
  * Other patients to be inappropriate to participate in the trial determined by the investigator

Primary outcomes:
measure: Composite of Stroke or Systemic arterial thromboembolism
timeFrame: 15 days after randomization
Secondary outcomes:
measure: Stroke
timeFrame: 15 days after randomization
measure: Systemic embolism
timeFrame: 15 days after randomization
measure: Death from any cause
timeFrame: 15 days after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-gu
city: Yeongdeungpo-gu
country: Korea, Republic of
facility: Yeouido St. Mary's hospital
state: Seoul
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincent hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
References: