A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
Inclusions at Screening
Signed informed consent must be obtained prior to participation in the study
Male and female participants ≥ 18 years of age
History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation
Permanent AF
Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)
History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.
Parallel
PKN605
DrugPKN605 is an oral formulation
Placebo
Other interventionMatching placebo
Atrial fibrillation burden from ECG patch monitors
Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time
Time from the date of randomization to first atrial fibrillation recurrence
Defined as the time (days) from the date of randomization to first atrial fibrillation recurrence
Presence of atrial fibrillation recurrence after randomization
Defined as presence of (or absence) of atrial fibrillation recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol approved method for ascertainment individually and as a composite
Pharmacokinetic Parameter: concentration
PKN605 plasma concentration
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