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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02750319
• Other study ID #: 16-307
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation in High Risk Patients
• Thoracic Surgery

Intervention

Drug:
• Amiodarone

• N-Acetylcysteine

• Placebo

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	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 Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey
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	University of Washington School of Medicine in St. Louis	Saint Louis	Missouri
United States	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	The Cleveland Clinic, Vanderbilt University School of Medicine, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center