Clinical trial NCT02750319: Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Thoracic Surgery
Atrial Fibrillation in High Risk Patients
Keywords: Amiodarone
N-Acetylcysteine
16-307
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: The Cleveland Clinic
name: Vanderbilt University School of Medicine
First posted: 2016-04-25
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
timeFrame: within 7 days since operation
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: University of Washington School of Medicine in St. Louis
state: Missouri
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre (Consent only)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Amar, MD
role: PRINCIPAL_INVESTIGATOR
References: