A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
29 de julio de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
158
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Quebec, Canadá, G1V 4G5
- Local Institution
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Alberta
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Edmonton, Alberta, Canadá, T6G 2B7
- Local Institution
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British Columbia
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New Westminster, British Columbia, Canadá, V3L 3W4
- Fraser Clinical Trials Inc.
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Ontario
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Cambridge, Ontario, Canadá, N1R 7R1
- Local Institution
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Grimsby, Ontario, Canadá, L3M 1P3
- Dr. Andy S.C. Lam Medicine Professional
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London, Ontario, Canadá, N6G 2V4
- Stroke Prevention & Artherosclerosis Research Centre
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Newmarket, Ontario, Canadá
- Local Institution
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Oshawa, Ontario, Canadá, L1J 2J9
- Local Institution
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Oshawa, Ontario, Canadá, L1J 2K1
- King Street Cardiology
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Toronto, Ontario, Canadá, M3M 3E5
- Local Institution
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Waterloo, Ontario, Canadá, N2T 0C1
- Local Institution
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Quebec
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Greenfield Park, Quebec, Canadá, J4V 2G8
- Viacar Recherche Clinique
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Montreal, Quebec, Canadá, H1T 1C8
- Local Institution
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Montreal, Quebec, Canadá, H2W 1T8
- Local Institution
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Terrebonne, Quebec, Canadá, J6V 2H2
- Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
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California
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Anaheim, California, Estados Unidos, 92801
- Oracle Clinical Research, Inc.
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Anaheim, California, Estados Unidos, 92801
- Cardiology Consultants Of Orange County Med. Group Inc
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Costa Mesa, California, Estados Unidos, 92626
- WCCT Global, LLC
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Long Beach, California, Estados Unidos, 90822
- Long Beach VA Medical Center
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Moreno Valley, California, Estados Unidos, 92553
- Spectrum Clinical Research
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Connecticut
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Waterbury, Connecticut, Estados Unidos, 06708
- Chase Medical Research, LLC
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Florida
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Cooper City, Florida, Estados Unidos, 33024
- ALL Medical Research, LLC
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Gainesville, Florida, Estados Unidos, 32605
- The Cardiac And Vascular Institute Research Foundation, Llc
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Lake Worth, Florida, Estados Unidos, 33462
- Acrc Cardiology
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Largo, Florida, Estados Unidos, 33770
- The Heart Institute at Largo
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Georgia
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Columbus, Georgia, Estados Unidos, 31904
- Columbus Regional Research Institute
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Indiana
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Anderson, Indiana, Estados Unidos, 46011
- Community Clinical Research Center
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Kansas
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Overland Park, Kansas, Estados Unidos, 66209
- Midwest Heart And Vascular Specialists, Llc.
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Louisiana
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Alexandria, Louisiana, Estados Unidos, 71301
- Cambridge Medical Trials
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Castlerock Clinical Research Consultants, Llc
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Pennsylvania
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Camp Hill, Pennsylvania, Estados Unidos, 17011
- Capital Area Research, LLC
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Tennessee
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Tullahoma, Tennessee, Estados Unidos, 37388
- Tennessee Center For Clinical Trials
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Texas
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Austin, Texas, Estados Unidos
- Local Institution
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Austin, Texas, Estados Unidos, 78705
- Local Institution
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Utah
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Layton, Utah, Estados Unidos, 84041
- Utah Cardiology P.C
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: 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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Experimental: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
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Experimental: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
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Experimental: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Periodo de tiempo: 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.
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Day 8 to Day 29
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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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
Periodo de tiempo: 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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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Cavg is defines as the average 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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Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
Periodo de tiempo: 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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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)
Periodo de tiempo: Day 8 to Day 29
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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.
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Day 8 to Day 29
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Total Number of Atrial Fibrillation Episodes
Periodo de tiempo: Day 8 to Day 29
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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
Periodo de tiempo: Day 8 to Day 29
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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.
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Day 8 to Day 29
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de julio de 2014
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2014
Publicado por primera vez (Estimar)
5 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CV205-005
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .