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 |
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.
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
Rockville Centre, New York 11570
Phone: 212-639-6798
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Phone: 212-639-6798
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650 Commack Road
Commack, New York 11725
Commack, New York 11725
Phone: 212-639-6798
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 212-639-6798
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480 Red Hill Road
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Phone: 212-639-6798
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225 Summit Avenue
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Phone: 212-639-6798
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1275 York Ave
New York, New York 10021
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...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Bryan Meyers, MD
Phone: 314-362-4533
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