Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02750319

Enrollment

184

Registered

2016-04-25

Start date

2016-04-01

Completion date

2027-04-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation in High Risk Patients, Thoracic Surgery

Keywords

Amiodarone, N-Acetylcysteine, 16-307

Brief summary

This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting \>30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days after major thoracic surgery.

Interventions

DRUGAmiodarone

DRUGN-Acetylcysteine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria: * 1\. Female \& BNP ≥ 25pg/ml (no age limit) * 2\. Male gender \<75 \& BNP ≥ 25pg/ml * 3\. Male- age ≥75 (No BNP limit) * 4\. History of prior AF * Patients in sinus rhythm. * Patients with stable respiratory status (no respiratory distress). * Patients capable of providing written, informed consent.

Exclusion criteria

* Patients scheduled for extrapleural pneumonectomy. * Hemodynamically unstable patients (not in cardiogenic shock or having an acute MI). * Patients with 2nd or 3rd degree atrioventricular (AV) block. * Patients with hypersensitivity to amiodarone or NAC. * Patients already taking class Ic or III antiarrhythmic drugs. * Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels). * Renal insufficiency (creatinine ≥2.0 mg/dl). * Known pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)	within 7 days since operation	Atrial arrhythmias will be considered and defined as atrial fibrillation/flutter (AF) lasting great than 30 seconds and/or sustained supraventricular tachycardia (SVT) that are detected by continuous telemetry or that are clinically significant, requiring intervention and documented by 12-lead ECG by the clinical staff.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Amar, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026