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

Phase 3

Active, not recruiting

• Conditions: Thoracic Surgery; Atrial Fibrillation in High Risk Patients
• Interventions: Drug: Amiodarone; Drug: Placebo; Drug: N-Acetylcysteine

• Registration Number: NCT02750319
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amiodarone + Placebo	Amiodarone	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.
Amiodarone + Placebo	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.
Amiodarone + N-Acetylcysteine	Amiodarone	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.
Amiodarone + N-Acetylcysteine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

University of Washington School of Medicine in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Rockville Centre (Consent only); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States