Phase 2 Study of Oral K201 for Prevention of AF Recurrence

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: K201 Tablet
* Drug: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo Tablet<br>* oral tablet, x28 days<br>|
| Experimental: Dose 1<br>K201 | Drug: K201 Tablet<br>* oral tablet, x28 days<br>|
| Experimental: Dose 2<br>K201 | Drug: K201 Tablet<br>* oral tablet, x28 days<br>|
| Experimental: Dose 3<br>K201 | Drug: K201 Tablet<br>* oral tablet, x28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, AF