drugset / Trial / NCT01924065

Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

NCT01924065

Phase 3 Completed 112 enrolled Suleyman Demirel University
RandomizedParallel-groupDouble-blindTreatment

Summary

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 instead 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.

Timeline

Start
2013-08
Primary completion
2017-08
Completion
2024-10-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Apixaban Small molecule Oral
Comparator Dabigatran etexilate Unknown Oral
Comparator Edoxaban Small molecule Oral
Comparator Rivaroxaban Other / unclassified Oral
Comparator Warfarin Small molecule Oral