Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in P… (NCT01199081) | Clinical Trial Compass
CompletedPhase 4
Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
Primary Objective:
\- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.
Secondary Objective:
* Explore potential PK interaction between Dronedarone and Amiodarone
* Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
* To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Screening:
* Paroxysmal or persistent AF having received at least 6 months of amiodarone before screening with at least the last 2 months at a regimen of 200 mg/day (during at least 5 days per week) prior to screening
* Requiring a change from amiodarone treatment whatever the reason, but without liver, lung or thyroid toxicity related to previous use of amiodarone
* At least one cardiovascular risk factor (i.e. age \> 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter \>= 50 mm
* Effective anticoagulation treatments verified by International Normalized Ratio (INR) (target INR \> 2)
* QTc Bazett \< 500 ms on 12-lead ECG
Randomization:
* Outpatients and Inpatients (except patients hospitalized during screening period for SAE)
* Sinus rhythm
* Effective oral anticoagulation treatment verified by INR (target INR \> 2). INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonist as per their label
* QTc Bazett \< 500 ms and PR \< 280 ms on 12-lead ECG
Exclusion criteria:
Screening:
* Contraindication to oral anticoagulation
* Acute condition known to cause AF
* Permanent AF
* Bradycardia \< 50 bpm at rest on the 12-lead ECG
* History of, or current heart failure or left ventricular systolic dysfunction
* Unstable hemodynamic conditions
* Severe hepatic impairment
* Wolff-Parkinson-White Syndrome
* Previous catheter ablation for atrial fibrillation or catheter ablation scheduled in t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma levels of dronedarone and its metabolite
Timeframe: At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose)