The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
7
Eastbourne General Hospital - Cardiology Department
Eastbourne, East Sussex, United Kingdom
AF burden reduction
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
Time frame: 113 Days
To assess the effect of ISIS CRP Rx on the:
* total number of AF episodes * average duration of AF per episode * average sinus rhythm duration * atrial and ventricular rate during AF episodes
Time frame: 113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
Time frame: 113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
Time frame: 113 Days
To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF
Change from Baseline will be compared for each treatment period
Time frame: 113 Days
To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF
Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group.
Time frame: 113 Days
To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF
Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group.
Time frame: 113 Days
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To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF
Trough levels of ISIS CRP Rx will be assessed at intervals throughout the study
Time frame: 113 Days