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
Colombia154 participantsStarted 2010-10
Plain-language summary
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 range18 Years
SexALL
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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…
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)