Amiodarone + N-Acetylcysteine for Atrial Fibrillation

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Class Ic, Class III

Disqualifiers: AV block, Hepatic insufficiency, Renal insufficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

184 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

David Amar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

My kidney function is impaired with high creatinine levels.

Known pregnancy

You are allergic to amiodarone or NAC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amiodarone and NAC or amiodarone and placebo to prevent atrial fibrillation after thoracic surgery

7 days

Continuous monitoring in PACU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amiodarone
• N-Acetylcysteine
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Amiodarone + N-Acetylcysteine Experimental Treatment 2 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 + Placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Vanderbilt University School of Medicine

Collaborator

Trials

16

Recruited

13,900+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+