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Antiarrhythmic Agent

Amiodarone + N-Acetylcysteine for Atrial Fibrillation

Phase 3
Waitlist Available
Led By David Amar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with stable respiratory status (no respiratory distress)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days since operation
Awards & highlights

Study Summary

This trial is testing whether adding NAC to amiodarone will reduce the rates of serious or clinically significant post-operative atrial fibrillation in high risk patients within 7 days of major thoracic surgery.

Who is the study for?
This trial is for adults over 18 who are having elective thoracic surgery and at high risk of post-operative atrial fibrillation (POAF). They must be stable, able to consent, in sinus rhythm, not pregnant, without severe liver or kidney issues, not on certain antiarrhythmics, and meet specific gender and biomarker criteria.Check my eligibility
What is being tested?
The study compares two groups: one receiving amiodarone with N-Acetylcysteine (NAC), the other getting amiodarone with a placebo. It aims to see if adding NAC reduces sustained or significant POAF within 7 days after major thoracic surgery in high-risk patients.See study design
What are the potential side effects?
Amiodarone may cause lung or liver problems, thyroid disorders, skin changes when exposed to sunlight, vision disturbances or heart complications. NAC might cause allergic reactions like rash or itching; gastrointestinal symptoms such as nausea; headache; fever; low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breathing is stable without distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days since operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days since operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Amiodarone + N-AcetylcysteineExperimental Treatment2 Interventions
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading: 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 and then continuously for 48 hours.
Group II: Amiodarone + PlaceboPlacebo Group2 Interventions
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading matching placebo; 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 NAC matched placebo continuously for 48 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470
Amiodarone
2010
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER
1,026 Previous Clinical Trials
1,365,892 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
5,527 Patients Enrolled for Atrial Fibrillation
Vanderbilt University School of MedicineOTHER
15 Previous Clinical Trials
13,757 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,436 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
5 Patients Enrolled for Atrial Fibrillation

Media Library

Amiodarone (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02750319 — Phase 3
Atrial Fibrillation Research Study Groups: Amiodarone + Placebo, Amiodarone + N-Acetylcysteine
Atrial Fibrillation Clinical Trial 2023: Amiodarone Highlights & Side Effects. Trial Name: NCT02750319 — Phase 3
Amiodarone (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02750319 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please compare and contrast other Amiodarone clinical trials?

"Amiodarone was first researched in 2002 by the Department of Anaesthesiology. Since then, there have been 18428 completed studies on this medication. As of now, 53 clinical trials are still recruiting patients. The majority of these active trials are based out of Montvale, New jersey."

Answered by AI

What is Amiodarone's most common indication?

"Amiodarone is most frequently used to treat acute rhinitis, though it can also be deployed against other conditions such as acetaminophen, vasomotor rhinitis, and cardiothoracic surgery."

Answered by AI

Is this study taking place in several different hospitals across North America?

"Currently, the 9 clinical trial sites for this study are up and running. The locations near Uniondale, Basking Ridge and Montvale, as well as other places, have been selected to make travel easy for participants."

Answered by AI

What is Amiodarone's standing with the FDA?

"Amiodarone's safety is estimated to be a 3. This evaluation comes from the fact that Phase 3 trials have some data supporting efficacy and multiple rounds of supportive safety data."

Answered by AI

How many participants can join this research project?

"Unfortunately, this particular trial is not currently seeking new participants. Although, it is worth noting that there are 518 other trials for atrial fibrillation and 53 clinical studies for Amiodarone which are both admitting patients."

Answered by AI

Are patients currently being accepted for this clinical trial?

"Unfortunately, this trial is no longer recruiting patients. The listing was created on April 1st, 2016 and last updated on March 22nd, 2022. However, there are 518 other clinical trials for atrial fibrillation and 53 more for Amiodarone that are still looking for participants."

Answered by AI

Is this clinical trial open to people who are not yet 50 years old?

"The requirements to participate in this trial state that applicants must be aged 18-75. However, there are 22 other trials for people who fall below the age of 18 and 555 studies available for patients above 65 years old."

Answered by AI

How can I get involved in this experiment?

"This medical study is looking for 184 patients aged 18-75 who have atrial fibrillation. Patients should meet the following criteria: stable respiratory status, sinus rhythm, male and age ≥75 (No BNP limit), and a history of prior AF."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
2016. "Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02750319.
~20 spots leftby Apr 2025
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