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NCT02750319 · ClinicalTrials.gov registry record · Phase 3
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
A Phase 3 study of Thoracic Surgery and Atrial Fibrillation in High Risk Patients, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
- 9
- Study locations
NCT02750319: Active Phase 3 study of Thoracic Surgery and Atrial Fibrillation in High Risk Patients, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02750319 is a Phase 3 study of Thoracic Surgery and Atrial Fibrillation in High Risk Patients that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 184 participants, above the 142-participant average among 5 other Thoracic Surgery trials with a reported enrollment target (30% higher). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02750319, a Phase 3 study of Thoracic Surgery and Atrial Fibrillation in High Risk Patients, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG N-Acetylcysteine
- DRUG Amiodarone
Study Locations (9)
New York
- Memorial Sloan Kettering Commack (Consent only) - Commack
- Memorial Sloan Kettering Westchester (Consent only) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre (Consent only) - Rockville Centre
- Memorial Sloan Kettering Nassau (Consent only) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Consent only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) - Middletown
- Memorial Sloan Kettering Bergen (Consent only) - Montvale
Missouri
- University of Washington School of Medicine in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2016-04 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT02750319 still lists
NCT02750319 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 5 other Thoracic Surgery trials with a reported enrollment target (30% higher).
The record links to 2 conditions, with Thoracic Surgery appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02750319 lists 9 locations in 3 states (New York, New Jersey, Missouri).
Frequently Asked Questions
What is clinical trial NCT02750319 about?
NCT02750319 is a clinical study titled "Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After 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...
What is the current status of trial NCT02750319?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2016-04. Estimated completion is 2026-04.
What conditions does trial NCT02750319 study?
This clinical trial studies the following conditions: Thoracic Surgery, Atrial Fibrillation in High Risk Patients.
What interventions are being tested in trial NCT02750319?
The interventions under investigation include: Placebo (DRUG), N-Acetylcysteine (DRUG), Amiodarone (DRUG).
Who is sponsoring clinical trial NCT02750319?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02750319 being conducted?
This trial has 9 study locations across Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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