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NCT Number: NCT02750319

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Thoracic Surgery Atrial Fibrillation in High Risk Patients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington School of Medicine in St. Louis, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amiodarone

Drug

N-acetylcysteine

Drug

Placebo

Drug

Primary outcomes

  1. rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • The Cleveland Clinic
  • Vanderbilt University School of Medicine
  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2016
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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