Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: BMS-914392

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356914

2010-022947-39 (EudraCT Number)

CV203-010

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

Treatment A: BMS-914392

Experimental group

Treatment:

Drug: BMS-914392

Drug: BMS-914392

Drug: BMS-914392

Treatment B: BMS-914392

Experimental group

Treatment:

Drug: BMS-914392

Drug: BMS-914392

Drug: BMS-914392

Treatment C: BMS-914392

Experimental group

Treatment:

Drug: BMS-914392

Drug: BMS-914392

Drug: BMS-914392

Treatment D: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo