A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
29. juli 2019 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
158
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec, Canada, G1V 4G5
- Local Institution
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Local Institution
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
- Fraser Clinical Trials Inc.
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Ontario
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Cambridge, Ontario, Canada, N1R 7R1
- Local Institution
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Grimsby, Ontario, Canada, L3M 1P3
- Dr. Andy S.C. Lam Medicine Professional
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London, Ontario, Canada, N6G 2V4
- Stroke Prevention & Artherosclerosis Research Centre
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Newmarket, Ontario, Canada
- Local Institution
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Oshawa, Ontario, Canada, L1J 2J9
- Local Institution
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Oshawa, Ontario, Canada, L1J 2K1
- King Street Cardiology
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Toronto, Ontario, Canada, M3M 3E5
- Local Institution
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Waterloo, Ontario, Canada, N2T 0C1
- Local Institution
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2G8
- Viacar Recherche Clinique
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Montreal, Quebec, Canada, H1T 1C8
- Local Institution
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Montreal, Quebec, Canada, H2W 1T8
- Local Institution
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Terrebonne, Quebec, Canada, J6V 2H2
- Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
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California
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Anaheim, California, Forente stater, 92801
- Oracle Clinical Research, Inc.
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Anaheim, California, Forente stater, 92801
- Cardiology Consultants Of Orange County Med. Group Inc
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Costa Mesa, California, Forente stater, 92626
- WCCT Global, LLC
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Long Beach, California, Forente stater, 90822
- Long Beach VA Medical Center
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Moreno Valley, California, Forente stater, 92553
- Spectrum Clinical Research
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Connecticut
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Waterbury, Connecticut, Forente stater, 06708
- Chase Medical Research, LLC
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Florida
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Cooper City, Florida, Forente stater, 33024
- ALL Medical Research, LLC
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Gainesville, Florida, Forente stater, 32605
- The Cardiac And Vascular Institute Research Foundation, Llc
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Lake Worth, Florida, Forente stater, 33462
- Acrc Cardiology
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Largo, Florida, Forente stater, 33770
- The Heart Institute at Largo
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Georgia
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Columbus, Georgia, Forente stater, 31904
- Columbus Regional Research Institute
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Indiana
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Anderson, Indiana, Forente stater, 46011
- Community Clinical Research Center
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Kansas
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Overland Park, Kansas, Forente stater, 66209
- Midwest Heart And Vascular Specialists, Llc.
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Louisiana
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Alexandria, Louisiana, Forente stater, 71301
- Cambridge Medical Trials
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74136
- Castlerock Clinical Research Consultants, Llc
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Pennsylvania
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Camp Hill, Pennsylvania, Forente stater, 17011
- Capital Area Research, LLC
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Tennessee
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Tullahoma, Tennessee, Forente stater, 37388
- Tennessee Center For Clinical Trials
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Texas
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Austin, Texas, Forente stater
- Local Institution
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Austin, Texas, Forente stater, 78705
- Local Institution
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Utah
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Layton, Utah, Forente stater, 84041
- Utah Cardiology P.C
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
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Eksperimentell: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
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Eksperimentell: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
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Eksperimentell: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Tidsramme: Day 8 to Day 29
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Tidsramme: Up to Day 50
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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.
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Up to Day 50
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Maximum Observed Concentarion (Cmax) of BMS-919373
Tidsramme: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
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Cmax is defined as the maximum observed concentration of BMS-919373.
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Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
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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)
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Ctrough is defined as the minimum estimated plasma concentration at steady state.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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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.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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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.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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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)
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Ka is the absorption rate constant.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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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)
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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.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
|
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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
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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.
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Day 8 to Day 29
|
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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
|
Samarbeidspartnere og etterforskere
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. juli 2014
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
12. mai 2014
Først innsendt som oppfylte QC-kriteriene
3. juni 2014
Først lagt ut (Anslag)
5. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CV205-005
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