Amiodarone + N-Acetylcysteine for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byDavid Amar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who are having elective thoracic surgery and at high risk of post-operative atrial fibrillation (POAF). They must be stable, able to consent, in sinus rhythm, not pregnant, without severe liver or kidney issues, not on certain antiarrhythmics, and meet specific gender and biomarker criteria.

Inclusion Criteria

My breathing is stable without distress.

Patients capable of providing written, informed consent

You have a regular heartbeat.

+1 more

Exclusion Criteria

My kidney function is impaired with high creatinine levels.

Known pregnancy

You are allergic to amiodarone or NAC.

+5 more

Participant Groups

The study compares two groups: one receiving amiodarone with N-Acetylcysteine (NAC), the other getting amiodarone with a placebo. It aims to see if adding NAC reduces sustained or significant POAF within 7 days after major thoracic surgery in high-risk patients.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Amiodarone + N-AcetylcysteineExperimental Treatment2 Interventions

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 II: Amiodarone + PlaceboPlacebo Group2 Interventions

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.