Atrial FibrillationPhase 3AFTER-CVNCT01924065

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

A Phase 3 study testing Cardioversion and Oral Anticoagulant in people with Atrial Fibrillation and Cardioversion, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke
What is being tested?: Cardioversion and Oral Anticoagulant
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Aug 2013to 29 Oct 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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Hyperthyroidism
History of malignancy
Left atrium diameter > 55 mm
Ejection fraction < 0.25

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Suleyman Demirel University
Isparta, Mediterranean Region, 32260

Other trials in Turkey (Türkiye)

About this study

Official title: Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

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
Being tested: Cardioversion, Oral Anticoagulant
Keywords: Atrial fibrillation, conversion, stroke
Medical subject headings: Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CardioversionProcedure or surgery
Electrical cardioversion
Oral AnticoagulantDrug
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Study groups in NCT01924065
Study group	Role	What they receive
Transesophageal Echocardiography group	Active comparator	This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion Receives: 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. Receives: Procedure: Cardioversion; Drug: Oral Anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 years
Efficacy Clinical End-point
Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Measured: 2 years
Ischemic Stroke/Transient Ischemic Attack
Measured: 2 years
Acute Ischemia in MRI
Development of acute silent cerebral ischemia detected by MRI
Measured: 1 week
Mortality
Measured: 2 years
Hemorrhagic Stroke
Measured: 2 years
Gastrointestinal Bleeding
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201329 Oct 2024

First posted16 Aug 2013 (estimated)
Study startAug 2013
Primary completionAug 2017
Study completion29 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924065
Sponsor's protocol ID: ozaydin291
Acronym: AFTER-CV
Status last verified: Oct 2024
First submitted: 7 Aug 2013
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
ClinicalTrials.gov ID: NCT01924065
Acronym / sponsor ID: AFTER-CV / ozaydin291
Conditions: Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke
Keywords: Atrial fibrillation, conversion, stroke
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Suleyman Demirel UniversityUniversity, hospital or other
Study start: Aug 2013
Primary completion: Aug 2017 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 16 Aug 2013 (estimated)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Transesophageal Echocardiography group	Active comparator	Procedure: CardioversionThis arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Oral anticoagulant Group	Active comparator	Procedure: Cardioversion, Drug: Oral AnticoagulantThis arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CardioversionElectrical cardioversion	Procedure or surgery	Oral anticoagulant Group, Transesophageal Echocardiography group
Oral Anticoagulantwarfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage	Drug	Oral anticoagulant Group

Primary outcome

Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
Time frame: 2 years
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Efficacy Clinical End-point
Time frame: 2 years
Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Ischemic Stroke/Transient Ischemic Attack
Time frame: 2 years
Acute Ischemia in MRI
Time frame: 1 week
Development of acute silent cerebral ischemia detected by MRI
Mortality
Time frame: 2 years
Hemorrhagic Stroke
Time frame: 2 years
Gastrointestinal Bleeding
Time frame: 2 years

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transesophageal Echocardiography Group	56	56
Oral Anticoagulant Group	56	56

Primary outcome: Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Transesophageal Echocardiography Group n = 56	Oral Anticoagulant Group n = 56
Value	9	11

Primary outcome: Efficacy Clinical End-point

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Transesophageal Echocardiography Group n = 56	Oral Anticoagulant Group n = 56
Value	7	9

Primary outcome: Ischemic Stroke/Transient Ischemic Attack

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Transesophageal Echocardiography Group n = 56	Oral Anticoagulant Group n = 56
Value	7	4

Primary outcome: Acute Ischemia in MRI

Time frame: 1 week. Count of participants. Unit: Participants

Measure	Transesophageal Echocardiography Group n = 56	Oral Anticoagulant Group n = 56
Value	2	4

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transesophageal Echocardiography Group	9 of 56 (16.1%)	0 of 56 (0%)	3 of 56
Oral Anticoagulation Group	10 of 56 (17.9%)	0 of 56 (0%)	2 of 56

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mehmet Ozaydin, Professor,MD principal investigator

Suleyman Demirel University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cardioversion and Oral Anticoagulant in people with Atrial Fibrillation and Cardioversion, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01924065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.