A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sequel Pharmaceuticals, Inc
- Enrollment
- 300
- Primary Endpoint
- proportion of subjects in sinus rhythm
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Placebo
Placebo
Intervention: Placebo Tablet (Drug)
Dose 1
K201
Intervention: K201 Tablet (Drug)
Dose 2
K201
Intervention: K201 Tablet (Drug)
Dose 3
K201
Intervention: K201 Tablet (Drug)
Outcomes
Primary Outcomes
proportion of subjects in sinus rhythm
Time Frame: Day 28
time to first documented recurrence of symptomatic or asymptomatic AF
Time Frame: 28 days
number of AF beats
Time Frame: 10 days
time to first documented recurrence of symptomatic AF
Time Frame: 28 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
Secondary Outcomes
No secondary outcomes reported