A Phase 4 interventional study of Amiodarone in Atrial Fibrillation, sponsored by Police General Hospital, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Police General Hospital, Thailand · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 24 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Police General Hospital, Thailand is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period. If the heart rate is still over 110 minutes after the initial treatment, provide an additional 150 mg IV amiodarone bolus over a 15-minute period. During the first 24 hours, this bolus may be administered up to three times in total. Within 24 hours of finishing the first bolus dosage, 900 mg of amiodarone will be administered intravenously.
Drug: Amiodarone
An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period, then a 24-hour amiodarone loading infusion 900 mg over 24 hours
Drug: Amiodarone
Assess the effectiveness of repeated bolus dosing strategies of amiodarone.
Heart rate
Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 6 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen
Time frame: 6-hours after receiving amiodarone bolus
Normal sinus rhythm at 24 hours
Percentage of patients who develop Atrial fibrillation with rapid ventricular response, the percentage of patients who have converted to sinus rhythm at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to sinus rhythm after a conventional amiodarone IV loading dose regimen
Time frame: 24-hours after receiving amiodarone bolus
Heart rate
Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 24 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen
Time frame: 24-hours after receiving amiodarone bolus
Major adverse cardiovascular events
Number of MACE \[MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death\]
Time frame: 30 days after receiving amiodarone bolus
Phlebitis
Rate of phlebitis complication during amiodarone infusion
Time frame: 24-hours after receiving amiodarone bolus
Changed in heart rate
Compare number of total heart rate induction in patients who received a repeated amiodarone bolus and loading dose regimen and a conventional amiodarone IV loading dose regimen at 24 hrs
Time frame: 24-hours after receiving amiodarone bolus
Ran from May 2024 to primary completion in Dec 2024, 7 months.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's 7 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amiodarone
Police General Hospital, Thailand