Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thor… (NCT02750319) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
United States184 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)