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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

Must not have

Renal insufficiency (creatinine ≥2.0 mg/dl)

Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 7 days since operation

Awards & highlights

Pivotal Trial

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.

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.

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

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My breathing is stable without distress.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is impaired with high creatinine levels.

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My liver tests are no more than twice the normal limit.

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I am not in cardiogenic shock or having a heart attack.

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I am currently on class Ic or III antiarrhythmic medication.

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I am scheduled for surgery to remove part of my lung and surrounding tissue.

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I have a type of heart block.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 7 days since operation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

death

100%

80%

60%

40%

20%

Study treatment Arm

Control

Amiodarone

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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