Phase 2 Study of Oral K201 for Prevention of AF Recurrence (ARCTIC-AF)

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

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 Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Placebo Tablet; Drug: K201 Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Tablet; oral tablet, x28 days
Experimental: Dose 1; K201	Drug: K201 Tablet; oral tablet, x28 days
Experimental: Dose 2; K201	Drug: K201 Tablet; oral tablet, x28 days
Experimental: Dose 3; K201	Drug: K201 Tablet; oral tablet, x28 days

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sequel Pharmaceuticals, Inc
• Investigators: Study Director: Paul Chamberlin, MD, Sequel Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 16, 2011
• Last Update Submitted That Met QC Criteria: May 13, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: atrial fibrillation; AF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: CJO-201