Thoracic SurgeryPhase 3NCT02750319
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
A Phase 3 study testing Amiodarone and N-Acetylcysteine in people with Thoracic Surgery and Atrial Fibrillation in High Risk Patients, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery, Atrial Fibrillation in High Risk Patients
- What is being tested?
- Amiodarone and N-Acetylcysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2016to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre (Consent only)
Rockville Centre, New York, 11570
University of Washington School of Medicine in St. Louis
St Louis, Missouri, 63110
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
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
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.
- Being tested
- Amiodarone, N-Acetylcysteine, Placebo
- Keywords
- Amiodarone, N-Acetylcysteine, 16-307
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
N-AcetylcysteineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone + Placebo | Placebo comparator | 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. Receives: Drug: Amiodarone; Drug: Placebo |
| Amiodarone + N-Acetylcysteine | Experimental | 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. Receives: Drug: Amiodarone; Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
Atrial arrhythmias will be considered and defined as atrial fibrillation/flutter (AF) lasting great than 30 seconds and/or sustained supraventricular tachycardia (SVT) that are detected by continuous telemetry or that are clinically significant, requiring intervention and documented by 12-lead ECG by the clinical staff.
Measured: within 7 days since operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine
- Responsible party
- Sponsor
- Investigators
- David Amar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750319
- Sponsor's protocol ID
- 16-307
- Status last verified
- May 2026
- First submitted
- 21 Apr 2016
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02750319
- Acronym / sponsor ID
- 16-307
- Keywords
- Amiodarone, N-Acetylcysteine, 16-307
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone + Placebo | Placebo comparator | Drug: Amiodarone, Drug: PlaceboAmiodarone 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. |
| Amiodarone + N-Acetylcysteine | Experimental | Drug: Amiodarone, Drug: N-AcetylcysteineAmiodarone 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Patients in sinus rhythm.
- Patients with stable respiratory status (no respiratory distress).
- Patients capable of providing written, informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone | Drug | Amiodarone + N-Acetylcysteine, Amiodarone + Placebo |
| N-Acetylcysteine | Drug | Amiodarone + N-Acetylcysteine |
| Placebo | Drug | Amiodarone + Placebo |
Primary outcome
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
Time frame: within 7 days since operation
Atrial arrhythmias will be considered and defined as atrial fibrillation/flutter (AF) lasting great than 30 seconds and/or sustained supraventricular tachycardia (SVT) that are detected by continuous telemetry or that are clinically significant, requiring intervention and documented by 12-lead ECG by the clinical staff.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Amar, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone and N-Acetylcysteine in people with Thoracic Surgery and Atrial Fibrillation in High Risk Patients, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF) (time frame: within 7 days since operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.