A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
29 juillet 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
158
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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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, États-Unis, 92801
- Oracle Clinical Research, Inc.
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Anaheim, California, États-Unis, 92801
- Cardiology Consultants Of Orange County Med. Group Inc
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Costa Mesa, California, États-Unis, 92626
- WCCT Global, LLC
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Long Beach, California, États-Unis, 90822
- Long Beach VA Medical Center
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Moreno Valley, California, États-Unis, 92553
- Spectrum Clinical Research
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Connecticut
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Waterbury, Connecticut, États-Unis, 06708
- Chase Medical Research, LLC
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Florida
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Cooper City, Florida, États-Unis, 33024
- ALL Medical Research, LLC
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Gainesville, Florida, États-Unis, 32605
- The Cardiac And Vascular Institute Research Foundation, Llc
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Lake Worth, Florida, États-Unis, 33462
- Acrc Cardiology
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Largo, Florida, États-Unis, 33770
- The Heart Institute at Largo
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Georgia
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Columbus, Georgia, États-Unis, 31904
- Columbus Regional Research Institute
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Indiana
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Anderson, Indiana, États-Unis, 46011
- Community Clinical Research Center
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Kansas
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Overland Park, Kansas, États-Unis, 66209
- Midwest Heart And Vascular Specialists, Llc.
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Louisiana
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Alexandria, Louisiana, États-Unis, 71301
- Cambridge Medical Trials
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74136
- Castlerock Clinical Research Consultants, Llc
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Pennsylvania
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Camp Hill, Pennsylvania, États-Unis, 17011
- Capital Area Research, LLC
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Tennessee
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Tullahoma, Tennessee, États-Unis, 37388
- Tennessee Center for Clinical Trials
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Texas
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Austin, Texas, États-Unis
- Local Institution
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Austin, Texas, États-Unis, 78705
- Local Institution
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Utah
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Layton, Utah, États-Unis, 84041
- Utah Cardiology P.C
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: 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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Expérimental: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
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Expérimental: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
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Expérimental: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 juillet 2014
Achèvement primaire (Réel)
1 juin 2016
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
12 mai 2014
Première soumission répondant aux critères de contrôle qualité
3 juin 2014
Première publication (Estimation)
5 juin 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juillet 2019
Dernière vérification
1 juillet 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CV205-005
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .