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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Thoracic Surgery, Atrial Fibrillation in High Risk Patients

In brief

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.

Key facts

Study ID

NCT02750319

Run by

Memorial Sloan Kettering Cancer Center

People needed

184

Starts

2016-04-01

Expected to finish

2027-04-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Washington School of Medicine in St. Louis — St Louis, Missouri, United States
• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre (Consent only) — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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