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Antiarrhythmic Agent

Oral Amiodarone for Atrial Fibrillation (AAA Trial)

Phase 4
Recruiting
Led By Satish R Raj, MD MSCI
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Appropriate anticoagulation (warfarin with an international normalized ratio (INR) > 2.0 or direct oral anticoagulant)
History of symptoms associated with atrial fibrillation
Must not have
Acute pulmonary oedema requiring hospital admission or New York Heart Association (NYHA) class IV heart failure
Received > 10 g of amiodarone in the prior 6 months, or other Class III anti-arrhythmic agents in the prior 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours of intervention administration
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test the safety and effectiveness of a high dose of the drug amiodarone for treating people with atrial fibrillation in both hospital and outpatient settings.

Who is the study for?
This trial is for adults with recent atrial fibrillation or flutter, confirmed by ECG, who have symptoms and are on blood thinners like warfarin or direct oral anticoagulants. It's not for those who've had a lot of amiodarone recently, bad reactions to cardioversion, severe heart issues, very low thyroid without treatment, serious kidney/liver disease, certain heart rhythm problems without a pacemaker, extremely low blood pressure or pregnant/breastfeeding women.
What is being tested?
The study tests if a high dose (2000mg) of Amiodarone given orally can safely and effectively treat acute atrial fibrillation in both hospital and outpatient settings compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and followed up after 48 hours.
What are the potential side effects?
Amiodarone may cause side effects such as thyroid disorders, lung inflammation, liver toxicity, skin reactions when exposed to sunlight (photosensitivity), vision disturbances and digestive issues. The severity of these side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on blood thinners with specific monitoring levels.
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I have experienced symptoms related to an irregular heartbeat.
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I have had atrial fibrillation or flutter for less than 14 days, confirmed by a heart monitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure or have been hospitalized for sudden lung swelling.
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I have not taken more than 10g of amiodarone or any Class III anti-arrhythmic drugs recently.
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I have an underactive thyroid and am not taking medication for it.
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I have a heart condition that affects my heart's rhythm but don't have a pacemaker.
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My heart's left chamber is weak, pumping less effectively.
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I have a diagnosed heart condition known as long QT syndrome.
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I have not had a heart attack in the last 2 weeks.
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I do not have severe kidney or liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours of intervention administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours of intervention administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Successful Reversion to Sinus Rhythm
Secondary study objectives
Conversion Rate to Sinus Rhythm
Early Recurrence of Atrial Fibrillation After Initial Reversion to Sinus Rhythm

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral AmiodaroneExperimental Treatment1 Intervention
Amiodarone hydrochloride 2000 mg
Group II: PlaceboPlacebo Group1 Intervention
Oral placebo

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,341 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,424 Patients Enrolled for Atrial Fibrillation
Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary
19 Previous Clinical Trials
1,384 Total Patients Enrolled

Media Library

Amiodarone Hydrochloride (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04594746 — Phase 4
Atrial Fibrillation Research Study Groups: Placebo, Oral Amiodarone
Atrial Fibrillation Clinical Trial 2023: Amiodarone Hydrochloride Highlights & Side Effects. Trial Name: NCT04594746 — Phase 4
Amiodarone Hydrochloride (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594746 — Phase 4
~22 spots leftby Dec 2027
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