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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02156076
• Other study ID #: CV205-005
• Status: Terminated
• Phase: Phase 2
• Start date: July 25, 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Drug:
• BMS-919373

• Placebo (Matching with BMS-919373)

Locations

Country	Name	City	State
Canada	Local Institution	Cambridge	Ontario
Canada	Local Institution	Edmonton	Alberta
Canada	Viacar Recherche Clinique	Greenfield Park	Quebec
Canada	Dr. Andy S.C. Lam Medicine Professional	Grimsby	Ontario
Canada	Stroke Prevention & Artherosclerosis Research Centre	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Fraser Clinical Trials Inc.	New Westminster	British Columbia
Canada	Local Institution	Newmarket	Ontario
Canada	King Street Cardiology	Oshawa	Ontario
Canada	Local Institution	Oshawa	Ontario
Canada	Local Institution	Quebec
Canada	Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur	Terrebonne	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Waterloo	Ontario
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Cardiology Consultants Of Orange County Med. Group Inc	Anaheim	California
United States	Oracle Clinical Research, Inc.	Anaheim	California
United States	Community Clinical Research Center	Anderson	Indiana
United States	Local Institution	Austin	Texas
United States	Local Institution	Austin	Texas
United States	Capital Area Research, Llc	Camp Hill	Pennsylvania
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	All Medical Research, Llc	Cooper City	Florida
United States	Wcct Global, Llc	Costa Mesa	California
United States	The Cardiac And Vascular Institute Research Foundation, Llc	Gainesville	Florida
United States	Acrc Cardiology	Lake Worth	Florida
United States	The Heart Institute At Largo	Largo	Florida
United States	Utah Cardiology P.C	Layton	Utah
United States	Long Beach Va Medical Center	Long Beach	California
United States	Spectrum Clinical Research	Moreno Valley	California
United States	Midwest Heart And Vascular Specialists, Llc.	Overland Park	Kansas
United States	Tennessee Center For Clinical Trials	Tullahoma	Tennessee
United States	Castlerock Clinical Research Consultants, Llc	Tulsa	Oklahoma
United States	Chase Medical Research, Llc	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System	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
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death	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
Secondary	Maximum Observed Concentarion (Cmax) of BMS-919373	Cmax is defined as the maximum observed concentration of BMS-919373.	Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Secondary	Trough Observed Concentration (Cmin) of BMS-919373	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)
Secondary	Oral Clearance (CL/F) of BMS-919373	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)
Secondary	Central Volume of Distribution (Vc/F) of BMS-919373	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)
Secondary	Absorption Rate Constant (Ka) of BMS-919373	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)
Secondary	Average Concentration (Cavg) of BMS-919373 at Steady State	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)
Secondary	Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373	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)
Secondary	Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)	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
Secondary	Total Number of Atrial Fibrillation Episodes	The total number AF episodes were derived from AF episode histogram data over the monitoring period.	Day 8 to Day 29
Secondary	Average Duration of Atrial Fibrillation Per Episode	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

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