Atrial FibrillationPhase 4NCT06262932
Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response
A Phase 4 study testing Amiodarone in people with Atrial Fibrillation, run by Police General Hospital, Thailand at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amiodarone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)
Who cannot join
- Baseline EKG Corrected QT interval (QTc) < 500 msec
- History of pulmonary fibrosis
- History of Cirrhosis
- Cardiac Index <2.2 L/min/m2 or Cardiogenic shock
- Unstable arrhythmia
- Receive amiodarone within 3 months prior to present illness
- Pregnancy
- Amiodarone or Iodine allergy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Repeated dosing regimen
- Standard dosing regimen
- Conditions
- Atrial Fibrillation
- Being tested
- Amiodarone
- 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
Assess the effectiveness of repeated bolus dosing strategies of amiodarone.
| Study group | Role | What they receive |
|---|---|---|
| Repeated amiodarone bolus dosing regimen | Active comparator | 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. Receives: Drug: Amiodarone |
| Standard dosing regimen | Active comparator | 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 Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-hours after receiving amiodarone bolus
Secondary outcomes (5)
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
Measured: 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
Measured: 24-hours after receiving amiodarone bolus
Major adverse cardiovascular events
Number of MACE [MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death]
Measured: 30 days after receiving amiodarone bolus
Phlebitis
Rate of phlebitis complication during amiodarone infusion
Measured: 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
Measured: 24-hours after receiving amiodarone bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Police General Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chawit Lopimpisuth, Police General Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262932
- Sponsor's protocol ID
- RADS regimen
- Status last verified
- Jan 2025
- First submitted
- 8 Feb 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response
- ClinicalTrials.gov ID
- NCT06262932
- Acronym / sponsor ID
- RADS regimen
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Police General Hospital, ThailandUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Feb 2024 (actual)
- 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.
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
- Repeated dosing regimen
- Standard dosing regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated amiodarone bolus dosing regimen | Active comparator | Drug: AmiodaroneAn 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. |
| Standard dosing regimen | Active comparator | Drug: AmiodaroneAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 years old
- Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)
Key exclusion criteria (8 listed)
- Baseline EKG Corrected QT interval (QTc) < 500 msec
- History of pulmonary fibrosis
- History of Cirrhosis
- Cardiac Index <2.2 L/min/m2 or Cardiogenic shock
- Unstable arrhythmia
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 |
|---|---|---|
| AmiodaroneAssess the effectiveness of repeated bolus dosing strategies of amiodarone. | Drug | Repeated amiodarone bolus dosing regimen, Standard dosing regimen |
Primary outcome
Heart rate
Time frame: 6-hours after receiving amiodarone bolus
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
5 secondary outcomes
Normal sinus rhythm at 24 hours
Time frame: 24-hours after receiving amiodarone bolus
Heart rate
Time frame: 24-hours after receiving amiodarone bolus
Major adverse cardiovascular events
Time frame: 30 days after receiving amiodarone bolus
Phlebitis
Time frame: 24-hours after receiving amiodarone bolus
Changed in heart rate
Time frame: 24-hours after receiving amiodarone bolus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiodarone in people with Atrial Fibrillation, run by Police General Hospital, Thailand at 1 site in Thailand.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate (time frame: 6-hours after receiving amiodarone bolus). 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 Jan 2025.