Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation (AFTER-CV)
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|ClinicalTrials.gov Identifier: NCT01924065|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2013
Last Update Posted : May 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Cardioversion Cerebrovascular Stroke||Procedure: Cardioversion Drug: Oral Anticoagulant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Transesophageal Echocardiography group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Active Comparator: Oral anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Drug: Oral Anticoagulant
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
- Ischemic stroke or silent cerebral thromboemboli [ Time Frame: 1 week ]clinical events or cerebral thromboemboli detected by diffusion magnetic resonance imaging
- Any clinical thromboembolic or hemorrhagic event or death [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924065
|Suleyman Demirel University|
|Isparta, Mediterranean Region, Turkey, 32260|
|Principal Investigator:||Mehmet Ozaydin, Professor,MD||Suleyman Demirel University|