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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067833
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : May 16, 2011
Information provided by:
Sequel Pharmaceuticals, Inc

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: K201 Tablet Drug: Placebo Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : April 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo Tablet
oral tablet, x28 days

Experimental: Dose 1
Drug: K201 Tablet
oral tablet, x28 days

Experimental: Dose 2
Drug: K201 Tablet
oral tablet, x28 days

Experimental: Dose 3
Drug: K201 Tablet
oral tablet, x28 days

Primary Outcome Measures :
  1. time to first documented recurrence of symptomatic AF [ Time Frame: 28 days ]
  2. time to first documented recurrence of symptomatic or asymptomatic AF [ Time Frame: 28 days ]
  3. proportion of subjects in sinus rhythm [ Time Frame: Day 28 ]
  4. number of AF beats [ Time Frame: 10 days ]
  5. time in AF [ Time Frame: 10 days ]
  6. safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events [ Time Frame: 42 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067833

Sponsors and Collaborators
Sequel Pharmaceuticals, Inc
Study Director: Paul Chamberlin, MD Sequel Pharmaceuticals

Responsible Party: Howard C. Dittrich, CMO, Sequel Pharmaceuticals, Inc Identifier: NCT01067833     History of Changes
Other Study ID Numbers: CJO-201
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by Sequel Pharmaceuticals, Inc:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes