Atrial FibrillationPhase 3NCT02715687
Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation, run by Rambam Health Care Campus.
Trial summary
Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiodarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All post-cardiac surgery patients who developed a hemodynamically stable postoperative atrial fibrillation and returned to sinus rhythm with intravenous amiodarone tretament.
Who cannot join
- Post-cardiac surgery patients who developed a non- hemodynamically stable postoperative atrial fibrillation.
- Patients with chronic and/or paroxysmal atrial fibrillation and/or known other cardiac arrhythmia or conduction disturbance.
- Patients with pacemakers.
- Patients with lactose intolerance
About this study
Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF.
the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
Read more
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
Read the detailed description
Atrial fibrillation (AF) is the most widespread complication encountered after cardiac surgery, associated with prolonged hospitalization, morbidity, mortality, and an annual cost of more than $1 billion to the American healthcare system.
AF has been reported to predict postoperative stroke, congestive heart failure, and late AF among patients undergoing mitral valve surgery. Postoperative AF (POAF) occurs in 62% of patients undergoing combined aortic valve and coronary artery bypass graft (CABG) surgery, in 49% of patients undergoing aortic valve surgery alone, in 42% of patients undergoing mitral valve surgery, and in 32% of patients undergoing CABG surgery alone. These figures are expected to rise in the future, given that the patients undergoing cardiac surgery are getting elder and that the incidence of AF in the general population is markedly age-dependent.
POAF peak incidence occurs on the 2nd and 3rd postoperative days (PODs). Seventy percent of patients develop this arrhythmia before the end of the 4th POD and 94% before the end of the 6th. Although generally well-tolerated and seen as a temporary problem related to surgery, POAF can be life-threatening, particularly in elderly patients and those with left ventricular dysfunction.
Recent guidelines for the prevention and management of POAF were jointly published in 2006 by the American College of Cardiology, the American Heart Association (AHA), and the European Society of Cardiology. These guidelines recommended (i) preoperative treatment with an oral beta-blocker drug for prevention of POAF as a class IA indication, and (ii) preoperative administration of amiodarone for patients at a high risk for POAF as a class IIA indication.
Amiodarone is associated with several complications, both cardiac, and extracardiac; among the cardiac complications, it is predominantly related to increased risk of bradycardia and hypotension, particularly when (i) administered intravenously, (ii) using average daily doses exceeding 1 g, and (iii) initiating prophylaxis during the postoperative period.45 Among the most severe extracardiac complications, amiodarone is associated with thyroid toxicity, lung fibrosis, and corneal damage, which may be aggravated by the drug's delayed onset of action (2 - 3 days) and long elimination half-life time (up to 6 months).
Currently the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Also called amiodacore
Will receive 30 days treatment with oral amniodarone of 200mg
PlaceboDrug
Will receive 30 days treatment with oral placebo of 200mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Will receive 30 days treatment with oral placebo of 200mg Receives: Drug: Placebo |
| Interventional | Active comparator | Will receive 30 days treatment with oral Amiodarone of 200mg Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
Post-discharge monitoring with a continous loop-recorder type of ECG monitoring device named "CardioR" will be provided for all participants. The device will continuously record and transmit ECG monitoring to a dedicated monitoring company. All arrhythmias will be recorded and reported.
Measured: 30 days after discharge
Secondary outcomes (1)
Post-discharge return to admission
Any return to admission will be recorded and reported.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziv Beckerman MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715687
- Sponsor's protocol ID
- AF Treatment
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.
- ClinicalTrials.gov ID
- NCT02715687
- Acronym / sponsor ID
- AF Treatment
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF.
the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
Detailed description
Atrial fibrillation (AF) is the most widespread complication encountered after cardiac surgery, associated with prolonged hospitalization, morbidity, mortality, and an annual cost of more than $1 billion to the American healthcare system.
AF has been reported to predict postoperative stroke, congestive heart failure, and late AF among patients undergoing mitral valve surgery. Postoperative AF (POAF) occurs in 62% of patients undergoing combined aortic valve and coronary artery bypass graft (CABG) surgery, in 49% of patients undergoing aortic valve surgery alone, in 42% of patients undergoing mitral valve surgery, and in 32% of patients undergoing CABG surgery alone. These figures are expected to rise in the future, given that the patients undergoing cardiac surgery are getting elder and that the incidence of AF in the general population is markedly age-dependent.
POAF peak incidence occurs on the 2nd and 3rd postoperative days (PODs). Seventy percent of patients develop this arrhythmia before the end of the 4th POD and 94% before the end of the 6th. Although generally well-tolerated and seen as a temporary problem related to surgery, POAF can be life-threatening, particularly in elderly patients and those with left ventricular dysfunction.
Recent guidelines for the prevention and management of POAF were jointly published in 2006 by the American College of Cardiology, the American Heart Association (AHA), and the European Society of Cardiology. These guidelines recommended (i) preoperative treatment with an oral beta-blocker drug for prevention of POAF as a class IA indication, and (ii) preoperative administration of amiodarone for patients at a high risk for POAF as a class IIA indication.
Amiodarone is associated with several complications, both cardiac, and extracardiac; among the cardiac complications, it is predominantly related to increased risk of bradycardia and hypotension, particularly when (i) administered intravenously, (ii) using average daily doses exceeding 1 g, and (iii) initiating prophylaxis during the postoperative period.45 Among the most severe extracardiac complications, amiodarone is associated with thyroid toxicity, lung fibrosis, and corneal damage, which may be aggravated by the drug's delayed onset of action (2 - 3 days) and long elimination half-life time (up to 6 months).
Currently the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWill receive 30 days treatment with oral placebo of 200mg |
| Interventional | Active comparator | Drug: AmiodaroneWill receive 30 days treatment with oral Amiodarone of 200mg |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All post-cardiac surgery patients who developed a hemodynamically stable postoperative atrial fibrillation and returned to sinus rhythm with intravenous amiodarone tretament.
Key exclusion criteria (4 listed)
- Post-cardiac surgery patients who developed a non- hemodynamically stable postoperative atrial fibrillation.
- Patients with chronic and/or paroxysmal atrial fibrillation and/or known other cardiac arrhythmia or conduction disturbance.
- Patients with pacemakers.
- Patients with lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmiodaroneAlso: amiodacoreWill receive 30 days treatment with oral amniodarone of 200mg | Drug | Interventional |
| PlaceboWill receive 30 days treatment with oral placebo of 200mg | Drug | Placebo |
Primary outcome
Postoperative atrial fibrillation
Time frame: 30 days after discharge
Post-discharge monitoring with a continous loop-recorder type of ECG monitoring device named "CardioR" will be provided for all participants. The device will continuously record and transmit ECG monitoring to a dedicated monitoring company. All arrhythmias will be recorded and reported.
1 secondary outcome
Post-discharge return to admission
Time frame: 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone in people with Atrial Fibrillation, run by Rambam Health Care Campus.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Postoperative atrial fibrillation (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2016.