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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours of intervention administration
Awards & highlights
AAA 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.Check my eligibility
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.See study design
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.
AAA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on blood thinners with specific monitoring levels.
Select...
I have experienced symptoms related to an irregular heartbeat.
Select...
I have had atrial fibrillation or flutter for less than 14 days, confirmed by a heart monitor.
AAA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours of intervention administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours of intervention administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Successful Reversion to Sinus Rhythm
Secondary outcome measures
Conversion Rate to Sinus Rhythm
Early Recurrence of Atrial Fibrillation After Initial Reversion to Sinus Rhythm
AAA 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
792 Previous Clinical Trials
869,112 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure or have been hospitalized for sudden lung swelling.I have not taken more than 10g of amiodarone or any Class III anti-arrhythmic drugs recently.I have an underactive thyroid and am not taking medication for it.I am on blood thinners with specific monitoring levels.I have a heart condition that affects my heart's rhythm but don't have a pacemaker.My heart's left chamber is weak, pumping less effectively.I have experienced symptoms related to an irregular heartbeat.I have a diagnosed heart condition known as long QT syndrome.I have not had a heart attack in the last 2 weeks.You had a serious health problem after a previous attempt to fix atrial fibrillation.I do not have severe kidney or liver disease.Your blood pressure is too low, with the top number below 90.I have had atrial fibrillation or flutter for less than 14 days, confirmed by a heart monitor.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Oral Amiodarone
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this trial enrolled thus far?
"Affirmative, the data on clinicaltrials.gov verifies that this trial is actively recruiting participants. It was first posted on February 3rd 2022 and underwent its last edit on February 7th of the same year. The research is currently looking for 42 applicants from a single site."
Answered by AI
What potential risks do patients face when taking Amiodarone Hydrochloride?
"Due to this being a Phase 4 trial, Amiodarone Hydrochloride's safety is believed to be very high and it was therefore assigned a score of 3 out of possible 3."
Answered by AI
What medical conditions is Amiodarone Hydrochloride utilized to address?
"Amiodarone Hydrochloride is a common prescription for atrial fibrillation, yet its benefits may extend to other cardiac conditions such as tachycardia, cardiothoracic surgery, ventricular and recurrent ventricular fibrillation."
Answered by AI
Is this experiment actively enlisting participants?
"Clinicaltrials.gov reports that this research protocol is presently enrolling patients, and has been since February 3rd 2022. The latest iteration of the study was updated on the 7th of February in 2021."
Answered by AI
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