Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02750319 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 3
Started2016-04
View on ClinicalTrials.gov ↗

Amendment history

2026-05-15
Study Status v20
Primary completion date2026-04→2027-04
Completion date2026-04→2027-04
2025-05-15
Study Status v19
Primary completion date2025-04→2026-04
Completion date2025-04→2026-04
2024-05-15
Study Status v18
Primary completion date2024-04→2025-04
Completion date2024-04→2025-04
2023-05-15
Study Status, Contacts/Locations v17
Primary completion date2023-04→2024-04
Completion date2023-04→2024-04
Study sites9 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge (Consent only)
2023-03-22
Study Status v16
Re-verified, no change to tracked fields
Show 15 earlier versions
2022-03-22
Study Status v15
Primary completion date2022-04→2023-04
Completion date2022-04→2023-04
2021-03-22
Study Status v14
Primary completion date2021-04→2022-04
Completion date2021-04→2022-04
2020-03-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 244→confirmed 184
Study sitesdetails revised at 9 of 9 sites
2020-02-18
Study Status v12
Primary completion date2020-04→2021-04
Completion date2020-04→2021-04
2019-09-04
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 9 sites
2019-05-14
Study Status v10
Re-verified, no change to tracked fields
2019-04-04
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 9 sites
2019-03-20
Study Status, Eligibility, Contacts/Locations v8
Primary completion date2019-04→2020-04
Completion date2019-04→2020-04
Study sites8→9
Eligibility criteria-30 characters
[...] ar (AV) block. Patients with hypersensitivity to amiodarone (including iodine allergy) 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.
2018-10-15
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 8 sites
2018-09-19
Study Status, Eligibility v6
Eligibility criteria+27 characters
[...] ar (AV) block. Patients with hypersensitivity to amiodarone (including iodine allergy) or NAC. Patients already taking class Ic or III antiarrhythmic drugs. Hepatic insufficiency (></= 1.52 times the upper normal limit of transaminase levels). Renal insufficiency (creatinine ≥2.0 mg/dl). Known pregnancy.
2018-08-21
Study Status, Contacts/Locations v5
Study sites7→8
2018-05-01
Study Status v4
Primary completion date2018-04→2019-04
Completion date2018-04→2019-04
2017-10-18
Study Status, Contacts/Locations v3
Study sites6→7
2017-06-20
Study Status, Contacts/Locations v2
Completion datenot stated→2018-04
Study sites4→6
2016-09-20
Study Status, Eligibility, Contacts/Locations v1
Study sites1→4
Eligibility criteria-61 characters
[...] of providing written, informed consent. Exclusion Criteria: Consented patients who have a lesser operation than planned. Patients scheduled for extrapleural pneumonectomy. Hemodynam [...]
2016-04-22
Original filing
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.
Trial Details
NCT Number NCT02750319
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine
Conditions Thoracic Surgery, Atrial Fibrillation in High Risk Patients
Enrollment 184 participants
Start Date 2016-04
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-19