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Active, not recruitingNCT02750319Updated May 19, 2026

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

A Phase 3 interventional study of Amiodarone and N-Acetylcysteine in Thoracic Surgery and Atrial Fibrillation in High Risk Patients, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Thoracic Surgery
  • Atrial Fibrillation in High Risk Patients

Keywords

  • Amiodarone
  • N-Acetylcysteine
  • 16-307
03

In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
184 participants (actual)

Study arms

  • Placebo comparator
    Amiodarone + Placebo

    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.

    Drug: Amiodarone · Drug: Placebo

  • Experimental
    Amiodarone + N-Acetylcysteine

    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.

    Drug: Amiodarone · Drug: N-Acetylcysteine

Interventions

  • DrugAmiodarone
  • DrugN-Acetylcysteine
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    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.

    Time frame: within 7 days since operation

07

Study locations

9 sites
  • University of Washington School of Medicine in St. Louis
    St Louis, Missouri 63110, United States
  • Memorial Sloan Kettering Basking Ridge (Consent only)
    Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth (Consent only)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen (Consent only)
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Commack (Consent only)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Consent only)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Rockville Centre (Consent only)
    Rockville Centre, New York 11570, United States
  • Memorial Sloan Kettering Nassau (Consent only)
    Uniondale, New York 11553, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02750319
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine
Responsible party
Sponsor
First posted
Apr 25, 2016
Start date
Apr 2016
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
May 19, 2026

Study contacts

David Amar, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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