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



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:3/24/2019
Start Date:April 2016
End Date:April 2020
Contact:David Amar, MD
Phone:212-639-6798

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
9
sites
1275 York Avenue
Rockville Centre, New York 11570
Phone: 212-639-6798
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-6798
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
650 Commack Road
Commack, New York 11725
Phone: 212-639-6798
?
mi
from
Commack, NY
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-6798
?
mi
from
Harrison, NY
Click here to add this to my saved trials
480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-6798
?
mi
from
Middletown, NJ
Click here to add this to my saved trials
225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-6798
?
mi
from
Montvale, NJ
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: David Amar, MD
Phone: 212-639-6798
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Bryan Meyers, MD
Phone: 314-362-4533
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Uniondale, New York 11553
Phone: 212-639-6798
?
mi
from
Uniondale, NY
Click here to add this to my saved trials