To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \>3 days and \<6 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
oral tablet, x28 days
oral tablet, x28 days
time to first documented recurrence of symptomatic AF
Time frame: 28 days
time to first documented recurrence of symptomatic or asymptomatic AF
Time frame: 28 days
proportion of subjects in sinus rhythm
Time frame: Day 28
number of AF beats
Time frame: 10 days
time in AF
Time frame: 10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Time frame: 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.