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

NCT02750319 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 16-307
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 9

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.

Conditions

Thoracic Surgery; Atrial Fibrillation in High Risk Patients

Keywords

Amiodarone; N-Acetylcysteine; 16-307

Outcome Measures

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.

  within 7 days since operation

Study Arms (2)

Amiodarone + Placebo

PLACEBO COMPARATOR

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

Amiodarone + N-Acetylcysteine

EXPERIMENTAL

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

Amiodarone DRUG

Amiodarone + N-Acetylcysteine; Amiodarone + Placebo

N-Acetylcysteine DRUG

Amiodarone + N-Acetylcysteine

Placebo DRUG

Amiodarone + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• \. Female \& BNP ≥ 25pg/ml (no age limit)
• \. Male gender \<75 \& BNP ≥ 25pg/ml
• \. Male- age ≥75 (No BNP limit)
• \. 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Washington University School of Medicine: collaborator
• The Cleveland Clinic: collaborator
• Vanderbilt University School of Medicine: collaborator

Study Sites (9)

University of Washington School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre (Consent only)

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Amiodarone; Acetylcysteine

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David Amar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (9)