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

2019年7月29日 更新者：Bristol-Myers Squibb

A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation

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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

158

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Quebec、加拿大、G1V 4G5
        • Local Institution
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2B7
        • Local Institution
    • British Columbia
      • New Westminster、British Columbia、加拿大、V3L 3W4
        • Fraser Clinical Trials Inc.
    • Ontario
      • Cambridge、Ontario、加拿大、N1R 7R1
        • Local Institution
      • Grimsby、Ontario、加拿大、L3M 1P3
        • Dr. Andy S.C. Lam Medicine Professional
      • London、Ontario、加拿大、N6G 2V4
        • Stroke Prevention & Artherosclerosis Research Centre
      • Newmarket、Ontario、加拿大
        • Local Institution
      • Oshawa、Ontario、加拿大、L1J 2J9
        • Local Institution
      • Oshawa、Ontario、加拿大、L1J 2K1
        • King Street Cardiology
      • Toronto、Ontario、加拿大、M3M 3E5
        • Local Institution
      • Waterloo、Ontario、加拿大、N2T 0C1
        • Local Institution
    • Quebec
      • Greenfield Park、Quebec、加拿大、J4V 2G8
        • Viacar Recherche Clinique
      • Montreal、Quebec、加拿大、H1T 1C8
        • Local Institution
      • Montreal、Quebec、加拿大、H2W 1T8
        • Local Institution
      • Terrebonne、Quebec、加拿大、J6V 2H2
        • Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
  • 美国
    • California
      • Anaheim、California、美国、92801
        • Oracle Clinical Research, Inc.
      • Anaheim、California、美国、92801
        • Cardiology Consultants Of Orange County Med. Group Inc
      • Costa Mesa、California、美国、92626
        • WCCT Global, LLC
      • Long Beach、California、美国、90822
        • Long Beach VA Medical Center
      • Moreno Valley、California、美国、92553
        • Spectrum Clinical Research
    • Connecticut
      • Waterbury、Connecticut、美国、06708
        • Chase Medical Research, LLC
    • Florida
      • Cooper City、Florida、美国、33024
        • ALL Medical Research, LLC
      • Gainesville、Florida、美国、32605
        • The Cardiac And Vascular Institute Research Foundation, Llc
      • Lake Worth、Florida、美国、33462
        • Acrc Cardiology
      • Largo、Florida、美国、33770
        • The Heart Institute at Largo
    • Georgia
      • Columbus、Georgia、美国、31904
        • Columbus Regional Research Institute
    • Indiana
      • Anderson、Indiana、美国、46011
        • Community Clinical Research Center
    • Kansas
      • Overland Park、Kansas、美国、66209
        • Midwest Heart And Vascular Specialists, Llc.
    • Louisiana
      • Alexandria、Louisiana、美国、71301
        • Cambridge Medical Trials
    • Oklahoma
      • Tulsa、Oklahoma、美国、74136
        • Castlerock Clinical Research Consultants, Llc
    • Pennsylvania
      • Camp Hill、Pennsylvania、美国、17011
        • Capital Area Research, LLC
    • Tennessee
      • Tullahoma、Tennessee、美国、37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Austin、Texas、美国
        • Local Institution
      • Austin、Texas、美国、78705
        • Local Institution
    • Utah
      • Layton、Utah、美国、84041
        • Utah Cardiology P.C

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
药品：Placebo (Matching with BMS-919373)
实验性的：Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
药品：BMS-919373
实验性的：Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
药品：BMS-919373
实验性的：Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
药品：BMS-919373

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
大体时间：Day 8 to Day 29
AFB is defined as the percent of time spent in atrial fibrillation (AF). AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system. This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days. The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB.
Day 8 to Day 29

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
大体时间：Up to Day 50
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.
Up to Day 50
Maximum Observed Concentarion (Cmax) of BMS-919373
大体时间：Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Cmax is defined as the maximum observed concentration of BMS-919373.
Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Trough Observed Concentration (Cmin) of BMS-919373
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Ctrough is defined as the minimum estimated plasma concentration at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Oral Clearance (CL/F) of BMS-919373
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Central Volume of Distribution (Vc/F) of BMS-919373
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Vc/F is a hypothetical volume into which a drug initially distributes upon administration.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Absorption Rate Constant (Ka) of BMS-919373
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Ka is the absorption rate constant.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Average Concentration (Cavg) of BMS-919373 at Steady State
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Cavg is defines as the average concentration at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
大体时间：Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
AUC is defined as the area under the concentration-time curve at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)
大体时间：Day 8 to Day 29
The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both "System-triggered" and "Patient-triggered" results and report them separately. "System-triggered" results will include both symptomatic and asymptomatic findings, while "Patient-triggered" results will be the symptomatic ones triggered to report by patients. The analysis will be done both for "System-triggered" and for "Patient-triggered" results.
Day 8 to Day 29
Total Number of Atrial Fibrillation Episodes
大体时间：Day 8 to Day 29
The total number AF episodes were derived from AF episode histogram data over the monitoring period.
Day 8 to Day 29
Average Duration of Atrial Fibrillation Per Episode
大体时间：Day 8 to Day 29
The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period.
Day 8 to Day 29

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年7月25日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2014年5月12日

首先提交符合 QC 标准的

2014年6月3日

首次发布 (估计)

2014年6月5日

研究记录更新

最后更新发布 (实际的)

2019年7月31日

上次提交的符合 QC 标准的更新

2019年7月29日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CV205-005

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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