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

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: BMS-914392; Drug: Placebo

• Registration Number: NCT01356914
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-15
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: BMS-914392	BMS-914392	-
Treatment B: BMS-914392	BMS-914392	-
Treatment D: Placebo	Placebo	-
Treatment C: BMS-914392	BMS-914392	-

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Burden	On Day 22 of each cross-over period

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events and type of adverse events	At Day 22 of each cross-over period
Number of Atrial fibrillation (AF) episodes	At Day 1 of each cross-over period
Number of AF episodes	At Day 22 of each cross-over period
Duration of AF episodes	At Day 22 of each cross-over period
Heart Rate	At Day 22 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period	At Day 22 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)	At Day 22 of each cross-over period
BMS-914392 plasma concentrations and exposures during each study period	At Days 1, 8 and 22 of each cross-over period

Trial Locations

Locations (1)

Eastbourne General Hospital; 🇬🇧 Eastbourne, United Kingdom