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

NCT01924065 | Completed Phase 3 Results

• 1 other identifier: ozaydin291
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Cardioversion; Cerebrovascular Stroke

Keywords

Atrial fibrillation, conversion, stroke

Outcome Measures

Primary Outcomes (7)

• Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli

  Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion

  2 years

• Efficacy Clinical End-point

  Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli

  2 years

• Ischemic Stroke/Transient Ischemic Attack

  2 years

• Acute Ischemia in MRI

  Development of acute silent cerebral ischemia detected by MRI

  1 week

• Mortality

  2 years

• Hemorrhagic Stroke

  2 years

• Gastrointestinal Bleeding

  2 years

Study Arms (2)

Transesophageal Echocardiography group

ACTIVE COMPARATOR

This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion

Procedure: Cardioversion

Oral anticoagulant Group

ACTIVE COMPARATOR

This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.

Procedure: Cardioversion; Drug: Oral Anticoagulant

Interventions

Cardioversion PROCEDURE

Electrical cardioversion

Oral anticoagulant Group; Transesophageal Echocardiography group

Oral Anticoagulant DRUG

warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Oral anticoagulant Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion

You may not qualify if:

• Urgent cardioversion
• Patients who have implanted pace-makers or other metal devices
• Claustrophobia
• Hematological disorders disabling patients to receive anticoagulant agents
• Atrial fibrillation secondary to temporary causes.
• Serious rheumatic heart valve disease
• Hyperthyroidism
• History of malignancy
• Left atrium diameter \> 55 mm
• Ejection fraction \< 0.25

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Mediterranean Region, 32260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Electric Countershock; Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

It is a small study. The inclusion criteria were very strict. Patients who required urgent cardioversion, had severe structural heart disease, or conditions that might precipitate atrial fibrillation and those who did not undergo cranial MRI were excluded. Most of the patients had new-onset atrial fibrillation. Therefore the findings of this study cannot be generalized for all atrial fibrillation patients.The evet rates in the both groups were low which decrease the power of the study.

Results Point of Contact

• Title: Mehmet Ozaydin
• Organization: Akdeniz Sifa Konyaalti Medical Center

mehmetozaydin@hotmail.com

905533354243

Study Officials

• Mehmet Ozaydin, Professor,MD

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor in Cardiology

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: October 29, 2024
• Last Updated: November 15, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)