Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, AF
Brief summary
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).
Interventions
DRUGK201 Tablet
oral tablet, x28 days
DRUGPlacebo Tablet
oral tablet, x28 days
Sponsors
Sequel Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic AF (sustained \>3 days and \<6 months) and clinically indicated for cardioversion; * Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice; * Hemodynamically stable (90 mmHg \< systolic blood pressure \< 190 mmHg)at screening and on Day 1;
Exclusion criteria
* Known prolonged QT syndrome or QTc interval of \>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT); * QRS \>0.130 sec; * Previous episodes of second- or third-degree atrioventricular block; * Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF; * Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD); * Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; * NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months; * Known concurrent temporary secondary causes of AF; * Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks; * Received treatment with other drugs known to prolong the QT interval within 5 half-lives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to first documented recurrence of symptomatic AF | 28 days |
| time to first documented recurrence of symptomatic or asymptomatic AF | 28 days |
| proportion of subjects in sinus rhythm | Day 28 |
| number of AF beats | 10 days |
| time in AF | 10 days |
| safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events | 42 days |
Outcome results
None listed