Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
- Registration Number
- NCT01259622
- Lead Sponsor
- Sequel Pharmaceuticals, Inc
- Brief Summary
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- Atrial fibrillation documented by ECG at the start of study drug infusion.
Exclusion Criteria
- Previous exposure to K201
- QTcF (Fridericia correction) >440 ms
- QRS interval > 140 ms
- Paced atrial or paced ventricular rhythm on ECG
- History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- History of amiodarone (oral or IV) in the last 3 months.
- Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- History of failed electrical cardioversion at any time in the past
- History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
- History or family history of Long QT Syndrome
- History of ventricular tachycardia requiring drug or device therapy
- Ejection fraction of 40% or less.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo saline - K201 K201 intravenous K201
- Primary Outcome Measures
Name Time Method proportion of subjects who convert to sinus rhythm 24 hours
- Secondary Outcome Measures
Name Time Method