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Antiarrhythmic Agent

Amiodarone to Prevent Post-operative Atrial Fibrillation (PREP-AF Trial)

N/A
Recruiting
Led By Andrew JE Seely, MD, PhD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon study completion, 1 year following study initiation
Awards & highlights

PREP-AF Trial Summary

This trial will assess the feasibility and safety of administering amiodarone to patients who are at high risk for developing atrial fibrillation after surgery.

Who is the study for?
This trial is for adults over 18 undergoing major lung or esophagus surgery who are at high risk of developing atrial fibrillation post-operation, as indicated by a prediction score. It excludes those with a history of certain heart conditions, current antiarrhythmic therapy, previous severe reaction to amiodarone, specific liver issues, and allergies to amiodarone.Check my eligibility
What is being tested?
The study tests the safety and feasibility of using Amiodarone versus a placebo in preventing irregular heart rhythm after lung or esophagus surgery in patients identified as high-risk. Participants will be randomly assigned to receive either Amiodarone or a placebo.See study design
What are the potential side effects?
Amiodarone can cause side effects such as issues with lung function (interstitial lung disease), liver toxicity (hepatotoxicity), changes in heart rhythm due to prolonged QTc interval, among others.

PREP-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for major lung or esophagus surgery.

PREP-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion, 1 year following study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon study completion, 1 year following study initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to safety protocol
Capability for enrolment
Intervention delivery
+5 more
Secondary outcome measures
Hospital length of stay
Incidence of postoperative atrial fibrillation
Other postoperative complications
+1 more

Side effects data

From 2008 Phase 4 trial • 130 Patients • NCT00127712
34%
Hypotension
2%
death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Amiodarone

PREP-AF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention ArmExperimental Treatment1 Intervention
Patients randomized to amiodarone treatment
Group II: Control ArmPlacebo Group1 Intervention
Patients randomized to placebo treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amiodarone
2010
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,637 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
5,733 Patients Enrolled for Atrial Fibrillation
Andrew JE Seely, MD, PhDPrincipal InvestigatorThe Ottawa Hospital
3 Previous Clinical Trials
322 Total Patients Enrolled

Media Library

Amiodarone (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04392921 — N/A
Atrial Fibrillation Research Study Groups: Control Arm, Intervention Arm
Atrial Fibrillation Clinical Trial 2023: Amiodarone Highlights & Side Effects. Trial Name: NCT04392921 — N/A
Amiodarone (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04392921 — N/A
~25 spots leftby Jun 2025
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