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

Bristol-Myers Squibb20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

BMS-914392DRUG

Tablets, Oral, 10 mg, Every Day (QD), 20 days

BMS-914392DRUG

Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days

BMS-914392DRUG

Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eastbourne General Hospital

Eastbourne, United Kingdom

Outcomes

Primary Outcomes

Atrial Fibrillation Burden

Time frame: At screening (baseline)

Atrial Fibrillation Burden

Time frame: Prior to randomization to study drug

Atrial Fibrillation Burden

Time frame: On Day 1 of each cross-over period

Atrial Fibrillation Burden

Time frame: On Day 8 of each cross-over period

Atrial Fibrillation Burden

Time frame: On Day 22 of each cross-over period

Secondary Outcomes

Number of participants with adverse events and type of adverse events

Time frame: At Day 1 of each cross-over period

Number of participants with adverse events and type of adverse events

Time frame: At Day 8 of each cross-over period

Number of participants with adverse events and type of adverse events

Time frame: At Day 22 of each cross-over period

Number of Atrial fibrillation (AF) episodes

Time frame: At Day 1 of each cross-over period

Number of AF episodes

Time frame: At Day 8 of each cross-over period

Number of AF episodes

Time frame: At Day 22 of each cross-over period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.