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Anti-arrhythmic agent
Amiodarone for Post-Operative Atrial Fibrillation (START-POAF Trial)
Phase 3
Recruiting
Led By William McIntyre, MD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization
Aged ≥18 years
Must not have
Documented preoperative history of paroxysmal, persistent or permanent AF
Planned use of a class I or III anti-arrhythmic drug (other than study drug)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will study the recurrence and impact of Atrial Fibrillation in patients who develop it after heart surgery.
Who is the study for?
This trial is for adults over 18 who've had cardiac surgery within the last two weeks and experienced new-onset AF or flutter. They should be ready to leave the hospital within two days of joining, and must not have started long-term anti-arrhythmic drugs.
What is being tested?
The START-POAF pilot study is testing if Amiodarone Hydrochloride (200 MG) can reduce Atrial Fibrillation recurrence after heart surgery. It's a randomized trial where outcomes are assessed without knowing which treatment was given.
What are the potential side effects?
Amiodarone may cause side effects like thyroid problems, liver issues, lung inflammation, skin reactions when exposed to sunlight, vision disturbances, and could affect the nervous system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had heart surgery, such as bypass or valve surgery, within the last 14 days.
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I am 18 years old or older.
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I am expected to receive a specific heart medication after surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of atrial fibrillation.
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I plan to use a specific heart rhythm medication not part of the study.
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I have had heart surgery, including a transplant, ventricular assist device, or AF ablation.
Select...
I cannot take amiodarone due to certain health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
3 patients per center per month
90% follow-up at 30 days
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
+1 moreSecondary study objectives
Burden of atrial fibrillation
Participants with at least one episode >6 minutes, >6 hours and >24 hours
Time to first AF > 6 minutes, >6 hours and >24 hours
Other study objectives
A composite of stroke, myocardial infarction and cardiovascular death
Atrial Fibrillation
Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Amiodarone maintenance therapyActive Control1 Intervention
Amiodarone 200 mg daily for four weeks
Group II: No Amiodarone maintenance therapyActive Control1 Intervention
No ongoing Amiodarone maintenance therapy for four weeks
Find a Location
Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
164 Previous Clinical Trials
718,114 Total Patients Enrolled
33 Trials studying Atrial Fibrillation
54,724 Patients Enrolled for Atrial Fibrillation
William McIntyre, MDPrincipal InvestigatorPopulation Health Research Institute