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AF burden (% time with any AF after direct current cardioversion, DCC). This is defined as the area under the curve for daily estimates (Day 8-Day 99). In case of repeated DCC, the burden for the day of DCC and all following days will be estimated as the median of burden from onset of the current AF episode until DCC.
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| Secondary Efficacy Endpoints |
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Recurrence rate (RecR) of persistent AF (defined as AF burden ≥ 23/24 h over 7 consecutive days) in at least one 7-day period
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Time-to-recurrence (TTR) defined as days from the successful cardioversion to first documented recurrence (TTR) of persistent AF (defined as AF burden ≥ 23/24 h over 7 consecutive days) in at least one 7-day period
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| Exploratory Efficacy Endpoints |
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RecR of non-persistent AF (defined as at least one AF episode not fulfilling the persistent AF definition)
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TTR of non-persistent AF (defined as at least one AF episode not fulfilling the persistent AF definition)
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AF burden during the first week of study drug intake prior to cardioversion
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AF burden during the first week of study drug intake prior to cardioversion compared to baseline
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AF burden after DCC compared to baseline
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Incidence of conversion to sinus rhythm during the first week of study drug intake prior to cardioversion
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Incidence of DCC procedures after successful DCC on Visit 4
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Incidence and duration of atrial flutter/atrial tachycardia
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Data collected from the patient diaries
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| Safety Endpoints |
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Incidence, severity, seriousness, and treatment-causality of AEs
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Clinically significant changes in safety laboratory evaluations, vital signs, 12 lead ECGs, ICM data, and physical examinations
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| Pharmacokinetic and Exploratory Pharmacodynamic Endpoints |
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Pharmacokinetic (evaluated by means of popPK analysis)
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Pharmacodynamic biomarker at baseline (Visit 3, Day 1) and at steady state (Visit 8, Day 99)
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Serum biomarkers (GDF-15, Galectin-3, NT-proANP, NT-proBNP)
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Metabolic biomarker (HbA1c, serum lipids)
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