A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.

Key facts

Study ID

NCT02156076

Run by

Bristol-Myers Squibb

People needed

158

Starts

2014-07-25

Expected to finish

2016-06-01

Last updated by the study team

2019-07-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting symptoms within 6 months prior to screening
• Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)
• Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured within 12 months of enrollment
• Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12 months of enrollment

You may not qualify if…

• Women of childbearing potential
• AFB < 3% or > 70%, during both screening periods independently
• Permanent or persistent Atrial Fibrillation
• Cardioversion within 3 months of study drug administration
• Stroke within 12 months of study drug administration
• TIA within 12 months of study drug administration
• Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with minimal exertion)
• Heart failure of NYHA class II (symptoms of heart failure with routine levels of exertion)with ejection fraction <40% as measured by echocardiography at any time within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥ 40% over this period will not counter this exclusion)
• Valvular heart disease (including any valvular insufficiency or stenosis greater than"mild")
• Ablation within 3 months of study enrollment

Where it is running

• Cardiology Consultants Of Orange County Med. Group Inc — Anaheim, California, United States
• Oracle Clinical Research, Inc. — Anaheim, California, United States
• Wcct Global, Llc — Costa Mesa, California, United States
• Long Beach Va Medical Center — Long Beach, California, United States
• Spectrum Clinical Research — Moreno Valley, California, United States
• Chase Medical Research, Llc — Waterbury, Connecticut, United States
• All Medical Research, Llc — Cooper City, Florida, United States
• The Cardiac And Vascular Institute Research Foundation, Llc — Gainesville, Florida, United States
• Acrc Cardiology — Lake Worth, Florida, United States
• The Heart Institute At Largo — Largo, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Community Clinical Research Center — Anderson, Indiana, United States
• Midwest Heart And Vascular Specialists, Llc. — Overland Park, Kansas, United States
• Cambridge Medical Trials — Alexandria, Louisiana, United States
• Castlerock Clinical Research Consultants, Llc — Tulsa, Oklahoma, United States
• Capital Area Research, Llc — Camp Hill, Pennsylvania, United States
• Tennessee Center For Clinical Trials — Tullahoma, Tennessee, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Austin, Texas, United States
• Utah Cardiology P.C — Layton, Utah, United States
• Local Institution — Edmonton, Alberta, Canada
• Fraser Clinical Trials Inc. — New Westminster, British Columbia, Canada
• Local Institution — Cambridge, Ontario, Canada
• Dr. Andy S.C. Lam Medicine Professional — Grimsby, Ontario, Canada
• Stroke Prevention & Artherosclerosis Research Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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