NCT02750319Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 184 (actual)
- First submitted
- 21 Apr 2016
- Start date
- 1 Apr 2016
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Atrial fibrillation
- NCT number
- NCT02750319
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 184
- From 1 Apr 2016 to the primary completion date, 30 Apr 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients already taking class Ic or III antiarrhythmic drugs.
Other illness
- Patients with hypersensitivity to amiodarone or NAC.
Lab values
- Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels).
- Renal insufficiency (creatinine ≥2.0 mg/dl).
Other
- 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.
- Known pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack (Consent only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Rockville Centre (Consent only) Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
| University of Washington School of Medicine in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Consent Only) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.