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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.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

158

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
薬：Placebo (Matching with BMS-919373)
実験的：Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
薬：BMS-919373
実験的：Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
薬：BMS-919373
実験的：Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
薬：BMS-919373

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Bristol-Myers Squibb

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年7月25日

一次修了 (実際)

2016年6月1日

研究の完了 (実際)

2016年6月1日

試験登録日

最初に提出

2014年5月12日

QC基準を満たした最初の提出物

2014年6月3日

最初の投稿 (見積もり)

2014年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月31日

QC基準を満たした最後の更新が送信されました

2019年7月29日

最終確認日

2019年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CV205-005

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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