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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Drug: BMS-919373; Drug: Placebo (Matching with BMS-919373)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156076

CV205-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 4 patient groups, including a placebo group

Arm A: Placebo (Matching with BMS-919373)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Matching with BMS-919373)

Arm B: BMS-919373

Experimental group

Description:

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

Treatment:

Drug: BMS-919373

Arm C: BMS-919373

Experimental group

Description:

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

Treatment:

Drug: BMS-919373

Arm D: BMS-919373

Experimental group

Description:

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

Treatment:

Drug: BMS-919373