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Antiarrhythmic Agent

Amiodarone for Preventing Postoperative Atrial Fibrillation

Phase 4
Recruiting
Led By Anson Lee, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair
No documented history of atrial fibrillation
Must not have
Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
Prior surgical procedures involving heart surgery and cardiopulmonary bypass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This trial is testing whether a medication called amiodarone can prevent a heart rhythm problem called atrial fibrillation (AF) after surgery.

Who is the study for?
This trial is for patients having their first non-emergency open-heart surgery, like bypass or valve repair, with a normal heart rhythm and no history of atrial fibrillation. It's not for those who've had previous heart surgeries using cardiopulmonary bypass, any past atrial arrhythmias lasting over 30 seconds, or prior Amiodarone use.
What is being tested?
The study tests if inducing and then treating atrial fibrillation (AF) during surgery can prevent postoperative AF. Patients with inducible AF are randomly chosen to receive Amiodarone treatment or no treatment; others get standard care. The goal is to see if this method predicts and reduces post-surgery AF.
What are the potential side effects?
Amiodarone may cause side effects such as skin reactions when exposed to sunlight, affecting the lungs leading to breathing issues, liver problems indicated by yellowing of the skin/eyes, thyroid disorders causing weight changes or energy levels alteration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for my first open-heart surgery for heart issues.
Select...
I have never been diagnosed with atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with Amiodarone for irregular heartbeats before.
Select...
I have had heart surgery with cardiopulmonary bypass.
Select...
I have had a heart rhythm problem lasting more than 30 seconds.
Select...
I need surgery for my irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Non-Inducible Atrial FibrillationExperimental Treatment1 Intervention
Amiodarone treatment if POAF seen on post-operative care unit
Group II: Inducible Atrial Fibrillation - Standard CareExperimental Treatment2 Interventions
No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Group III: Inducible Atrial FibrillationActive Control2 Interventions
Treatment with Amiodarone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amiodarone
FDA approved

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,612 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
425,020 Patients Enrolled for Atrial Fibrillation
Anson Lee, MDPrincipal InvestigatorStanford University

Media Library

Amiodarone Injection (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03868150 — Phase 4
Atrial Fibrillation Research Study Groups: Inducible Atrial Fibrillation - Standard Care, Non-Inducible Atrial Fibrillation, Inducible Atrial Fibrillation
Atrial Fibrillation Clinical Trial 2023: Amiodarone Injection Highlights & Side Effects. Trial Name: NCT03868150 — Phase 4
Amiodarone Injection (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868150 — Phase 4
~262 spots leftby Dec 2030
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