Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation "AFTER-CV"

Active, not recruiting

Phase 3 Results N/A

Trial Description

Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent istead of warfarin for 3 weeks.
If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
    ARM 1: Kind: Experimental
    Label: Warfarin Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin four weeks before electrical cardioversion.
  • Cardioversion Procedure
    Intervention Desc: Electrical cardioversion
    ARM 1: Kind: Experimental
    Label: Transesophageal Echocardiography group
    Description: This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
    ARM 2: Kind: Experimental
    Label: Warfarin Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin four weeks before electrical cardioversion.
    ARM 3: Kind: Experimental
    Label: Oral anticoagulant Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
  • Oral Anticoagulant Drug
    Intervention Desc: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
    ARM 1: Kind: Experimental
    Label: Oral anticoagulant Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke 1 week Yes
Secondary silent cerebral thromboemboli 1 week Yes
Secondary bleeding 1 week Yes
Primary Ischemic stroke or silent cerebral thromboemboli 1 week
Secondary Clinical thromboembolic events 1 week
Secondary Any clinical thromboembolic or hemorrhagic event 1 month
Secondary Any clinical thromboembolic or hemorrhagic event or death 1 month

Sponsors