Back to resultsPhase 2 Study of Oral K201 for Prevention of AF Recurrence (ARCTIC-AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
K201 Tablet
Placebo Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, AF
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Dose 1
Dose 2
Dose 3
Arm Description
Placebo
K201
K201
K201
Outcomes
Primary Outcome Measures
time to first documented recurrence of symptomatic AF
time to first documented recurrence of symptomatic or asymptomatic AF
proportion of subjects in sinus rhythm
number of AF beats
time in AF
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01067833
First Posted
February 10, 2010
Last Updated
May 13, 2011
Sponsor
Sequel Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01067833
Brief Title
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
Acronym
ARCTIC-AF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sequel Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, AF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
K201
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
K201
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
K201
Intervention Type
Drug
Intervention Name(s)
K201 Tablet
Intervention Description
oral tablet, x28 days
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
oral tablet, x28 days
Primary Outcome Measure Information:
Title
time to first documented recurrence of symptomatic AF
Time Frame
28 days
Title
time to first documented recurrence of symptomatic or asymptomatic AF
Time Frame
28 days
Title
proportion of subjects in sinus rhythm
Time Frame
Day 28
Title
number of AF beats
Time Frame
10 days
Title
time in AF
Time Frame
10 days
Title
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chamberlin, MD
Organizational Affiliation
Sequel Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
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