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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-25

Study Completion Date

2016-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A: Placebo (Matching with BMS-919373)

Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days

Group Type PLACEBO_COMPARATOR

Placebo (Matching with BMS-919373)

Intervention Type DRUG

Arm B: BMS-919373

BMS-919373 3 mg tablets orally once daily for approximately 28 days

Group Type EXPERIMENTAL

BMS-919373

Intervention Type DRUG

Arm C: BMS-919373

BMS-919373 5 mg tablets orally once daily for approximately 28 days

Group Type EXPERIMENTAL

BMS-919373

Intervention Type DRUG

Arm D: BMS-919373

BMS-919373 12 mg tablets orally once daily for approximately 28 days

Group Type EXPERIMENTAL

BMS-919373

Intervention Type DRUG

Interventions

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BMS-919373

Intervention Type DRUG

Placebo (Matching with BMS-919373)

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No