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

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ClinicalTrials.gov Identifier: NCT02750319
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Washington University School of Medicine
The Cleveland Clinic
Vanderbilt University School of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Thoracic Surgery Atrial Fibrillation in High Risk Patients Drug: Amiodarone Drug: N-Acetylcysteine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Amiodarone + Placebo
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.
Drug: Amiodarone
Drug: Placebo
Experimental: Amiodarone + N-Acetylcysteine
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.
Drug: Amiodarone
Drug: N-Acetylcysteine



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750319


Contacts
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Contact: David Amar, MD 212-639-6798
Contact: David R Jones, MD 212-639-6428

Locations
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United States, Missouri
University of Washington School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Bryan Meyers, MD    314-362-4533      
Principal Investigator: Bryan Meyers, MD         
United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only) Recruiting
Basking Ridge, New Jersey, United States
Contact: David Amar, MD    212-639-6798      
Memorial Sloan Kettering Monmouth (Consent only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: David Amar, MD    212-639-6798      
Memorial Sloan Kettering Bergen (Consent only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: David Amar, MD    212-639-6798      
United States, New York
Memorial Sloan Kettering Commack (Consent only) Recruiting
Commack, New York, United States, 11725
Contact: David Amar, MD    212-639-6798      
Memorial Sloan Kettering Westchester (Consent only) Recruiting
Harrison, New York, United States, 10604
Contact: David Amar, MD    212-639-6798      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: David Amar, MD    212-639-6798      
Contact: David R Jones, MD    212-639-6428      
Principal Investigator: David Amar, MD         
Memorial Sloan Kettering Rockville Centre (Consent only) Recruiting
Rockville Centre, New York, United States, 11570
Contact: David Amar, MD    212-639-6798      
Memorial Sloan Kettering Nassau (Consent only) Recruiting
Uniondale, New York, United States, 11553
Contact: David Amar, MD    212-639-6798      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Washington University School of Medicine
The Cleveland Clinic
Vanderbilt University School of Medicine
Investigators
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Principal Investigator: David Amar, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02750319     History of Changes
Other Study ID Numbers: 16-307
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Amiodarone
N-Acetylcysteine
16-307

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Amiodarone
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors