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Postoperative Atrial FibrillationPhase 3NCT02132767

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

A Phase 3 study testing Amiodarone and DC-cardioversion in people with Postoperative Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Atrial Fibrillation
What is being tested?
Amiodarone and DC-cardioversion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
523 participants
Where
23 sitesin 2 countries
Study dates
May 2014to Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • LVAD insertion or heart transplantation
  • Maze procedure
  • TAVR
  • History of or planned mechanical valve replacement
  • Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)
  • History of AF or AFL
Show all 10Show fewer
  • History of AF or AFL ablation
  • Contraindications to warfarin or amiodarone
  • Need for long-term anticoagulation
  • Concurrent participation in an interventional (drug or device) trial

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States17 sites

  • University of Michigan Health Services

    Ann Arbor, Michigan, 48109

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University

    Atlanta, Georgia, 30308

  • University of Maryland

    Baltimore, Maryland, 21201

  • NIH Heart Center at Suburban Hospital

    Bethesda, Maryland, 20814

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27710

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Baylor Research Institute

    Plano, Texas, 75093

  • Montefiore Einstein Heart Center

    The Bronx, New York, 10467

Other trials in United States

Canada6 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2W 1T8

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C5

  • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

    Québec, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

Read the detailed description

The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.

Being tested
Amiodarone, DC-cardioversion, Rate Control
Keywords
Heart surgery, Cardiac surgery, Coronary artery bypass, Mitral valve surgery, Aortic valve surgery, Atrial fibrillation, Atrial flutter, Cardiac arrhythmia, Valve surgery
Medical subject headings
Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmiodaroneDrug

    Also called Cordarone

    Amiodarone Initial Dose

    • Oral: 400 mg po TID for 3 days is recommended
    • For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
    • Oral: at least 200 mg/day to be continued until 60 days after randomization
    • If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started

  • DC-cardioversionProcedure or surgery

    Also called Direct Current Cardioversion

    DC-Cardioversion - frequency and duration determined by medical professional as medically needed

  • Rate ControlDrug

    Also called Beta-blocker, Calcium channel blockers, Digoxin

    Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed

Study groups in NCT02132767
Study groupRoleWhat they receive
Rhythm controlActive comparatorRhythm Control in post-operative AF Amiodarone and/or DC-cardioversion Amiodarone Initial Dose * Oral: 400 mg po TID for 3 days is recommended * For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose * Oral: at least 200 mg/day to be continued until 60 days after randomization * If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started DC-Cardioversion - frequency and duration determined by medical professional as medically needed
Receives: Drug: Amiodarone; Procedure: DC-cardioversion
Rate controlActive comparatorRate Control in post-operative AF Beta-blocker and/or Calcium channel blockers and/or Digoxin Dose, frequency and duration determined by medical professional as medically needed
Receives: Drug: Rate Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Days in Hospital

    The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.

    Measured: Within 60 days of randomization

Secondary outcomes (9)

  1. Time to Conversion to Sustained, Stable Non-AF Rhythm

    Measured: Up to index hospital discharge or 7 days post surgery, whichever came first

  2. Heart Rhythm Comparison

    Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge

    Measured: Hospital discharge

  3. Heart Rhythm Comparison

    Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization

    Measured: 30 days after randomization

  4. Heart Rhythm Comparison

    Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization

    Measured: 60 days after randomization

  5. Length of Stay (Index Hospitalization)

    Overall length of stay for the index hospitalization

    Measured: Within 60 days post surgery

  6. Length of Stay (Rehospitalization, Including ED Visits)

    Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits

    Measured: Within 60 days of randomization

  7. Outpatient Interventions

    Compare frequency of outpatient visits between groups for any cause and AF-related causes

    Measured: Within 60 days of randomization

  8. AF- or Treatment-related Events

    Measured: Within 60 days of randomization

  9. Cost (Hospital)

    Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups

    Measured: Within 60 days of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
523 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02132767
Sponsor's protocol ID
GCO 08-1078-00007
Other IDs
5U01HL088942-08
Status last verified
Feb 2019
First submitted
5 May 2014
Last updated
15 Mar 2019
Data monitoring committee
Yes

Publications

  • Afifi A. CTS trials network: Rate control vs rhythm control for atrial fibrillation after cardiac surgery - Do bitter pills have blessed effects? Glob Cardiol Sci Pract. 2016 Jun 30;2016(2):e201615. doi: 10.21542/gcsp.2016.15.

    PubMed 29043263

  • Gillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O'Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O'Gara PT, Mack MJ; CTSN. Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med. 2016 May 19;374(20):1911-21. doi: 10.1056/NEJMoa1602002. Epub 2016 Apr 4.

    PubMed 27043047

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amiodarone and DC-cardioversion in people with Postoperative Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Days in Hospital (time frame: Within 60 days of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02132767, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.

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