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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure

NCT00739193

Blood Pressure

WITHDRAWN PHASE2

Rapid Atrial Fibrillation Treatment Strategy

NCT04092621

New Onset Atrial Fibrillation Sepsis Respiratory Failure

UNKNOWN PHASE4

Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation

NCT07273994

Persistent Atrial Fibrillation

RECRUITING PHASE4

Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm

NCT00007605

Atrial Fibrillation Cerebrovascular Accident Death, Sudden

COMPLETED PHASE3

Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation

NCT04684056

Oral Anticoagulant Atrial Fibrillation Pharmacokinetics and Pharmacodynamics

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Surgery Atrial Fibrillation in High Risk Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amiodarone + Placebo

Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading matching placebo; 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 NAC matched placebo continuously for 48 hours.

Group Type PLACEBO_COMPARATOR

Amiodarone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Amiodarone + N-Acetylcysteine

Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading: 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 and then continuously for 48 hours.

Group Type EXPERIMENTAL

Amiodarone

Intervention Type DRUG

N-Acetylcysteine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amiodarone

Intervention Type DRUG

N-Acetylcysteine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No