Atrial Fibrillation
Conditions
Brief summary
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.
Interventions
DRUGBMS-914392
Tablets, Oral, 10 mg, Every Day (QD), 20 days
DRUGPlacebo
Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Paroxysmal atrial fibrillation (AF) * Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics. * 1-50% AF burden on pacemaker interrogation at screening. * Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.
Exclusion criteria
* Persistent or permanent AF. * AF Burden \<1% or \> 50%. * Current or history of neurological diseases and mental disorders. * Ejection Fraction \< 45%. * Severe mitral or aortic valve dysfunction. * TIA (Transient Ischemic Attack) within last 12 months. * Acute coronary syndrome in the last 2 months. * Previous AF ablation. * Cardioversion in last 3 months. * Current kidney or liver disease, or current cancer. * History of neurological and mental disorders. * Major surgery within 4 weeks of first dose (cardiac surgery within 4 months). * Screening lab test results outside of allowed limits per protocol. * QTcF \> 450 msec.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation Burden | At screening (baseline) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events and type of adverse events | At Day 1 of each cross-over period |
| Number of Atrial fibrillation (AF) episodes | At Day 1 of each cross-over period |
| Number of AF episodes | At Day 8 of each cross-over period |
| Severity of AF (SAF) scale score at the end of each study period | At Day 1 of each cross-over period |
| Heart Rate | At Day 1 of each cross-over period |
| Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) | At Day 1 of each cross-over period |
| BMS-914392 plasma concentrations and exposures during each study period | At Days 1, 8 and 22 of each cross-over period |
| Duration of AF episodes | At Day 1 of each cross-over period |
Countries
United Kingdom
Outcome results
None listed