Clinical trial NCT02156076: A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Primary Purpose: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
timeFrame: Day 8 to Day 29
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
timeFrame: Up to Day 50
measure: Maximum Observed Concentarion (Cmax) of BMS-919373
timeFrame: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
measure: Trough Observed Concentration (Cmin) of BMS-919373
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Oral Clearance (CL/F) of BMS-919373
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Central Volume of Distribution (Vc/F) of BMS-919373
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Absorption Rate Constant (Ka) of BMS-919373
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Average Concentration (Cavg) of BMS-919373 at Steady State
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
timeFrame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
measure: Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)
timeFrame: Day 8 to Day 29
measure: Total Number of Atrial Fibrillation Episodes
timeFrame: Day 8 to Day 29
measure: Average Duration of Atrial Fibrillation Per Episode
timeFrame: Day 8 to Day 29
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Cardiology Consultants Of Orange County Med. Group Inc
state: California
city: Anaheim
country: United States
facility: Oracle Clinical Research, Inc.
state: California
city: Costa Mesa
country: United States
facility: Wcct Global, Llc
state: California
city: Long Beach
country: United States
facility: Long Beach Va Medical Center
state: California
city: Moreno Valley
country: United States
facility: Spectrum Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, Llc
state: Connecticut
city: Cooper City
country: United States
facility: All Medical Research, Llc
state: Florida
city: Gainesville
country: United States
facility: The Cardiac And Vascular Institute Research Foundation, Llc
state: Florida
city: Lake Worth
country: United States
facility: Acrc Cardiology
state: Florida
city: Largo
country: United States
facility: The Heart Institute At Largo
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Overland Park
country: United States
facility: Midwest Heart And Vascular Specialists, Llc.
state: Kansas
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants, Llc
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, Llc
state: Pennsylvania
city: Tullahoma
country: United States
facility: Tennessee Center For Clinical Trials
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Layton
country: United States
facility: Utah Cardiology P.C
state: Utah
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: Cambridge
country: Canada
facility: Local Institution
state: Ontario
city: Grimsby
country: Canada
facility: Dr. Andy S.C. Lam Medicine Professional
state: Ontario
city: London
country: Canada
facility: Stroke Prevention & Artherosclerosis Research Centre
state: Ontario
city: Newmarket
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa
country: Canada
facility: King Street Cardiology
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Waterloo
country: Canada
facility: Local Institution
state: Ontario
city: Greenfield Park
country: Canada
facility: Viacar Recherche Clinique
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Terrebonne
country: Canada
facility: Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: