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

29. juli 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

158

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
Medicin: Placebo (Matching with BMS-919373)
Eksperimentel: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
Medicin: BMS-919373
Eksperimentel: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
Medicin: BMS-919373
Eksperimentel: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
Medicin: BMS-919373

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juli 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

12. maj 2014

Først indsendt, der opfyldte QC-kriterier

3. juni 2014

Først opslået (Skøn)

5. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CV205-005

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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