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

NCT02156076 | Terminated Phase 2 Results

• 1 other identifier: CV205-005
• Study Type: interventional
• Target: 158
• Locations: 2 countries
• Sites: 35

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death

  Up to Day 50

• Maximum Observed Concentarion (Cmax) of BMS-919373

  Day 1 and Day 22: Predose 1, 2, and 4 hours postdose

• Trough Observed Concentration (Cmin) of BMS-919373

  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

  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

  Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)

Study Arms (4)

Arm A: Placebo (Matching with BMS-919373)

PLACEBO COMPARATOR

Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days

Drug: Placebo (Matching with BMS-919373)

Arm B: BMS-919373

EXPERIMENTAL

BMS-919373 3 mg tablets orally once daily for approximately 28 days

Drug: BMS-919373

Arm C: BMS-919373

EXPERIMENTAL

BMS-919373 5 mg tablets orally once daily for approximately 28 days

Drug: BMS-919373

Arm D: BMS-919373

EXPERIMENTAL

BMS-919373 12 mg tablets orally once daily for approximately 28 days

Drug: BMS-919373

Interventions

BMS-919373 DRUG

Arm B: BMS-919373; Arm C: BMS-919373; Arm D: BMS-919373

Placebo (Matching with BMS-919373) DRUG

Arm A: Placebo (Matching with BMS-919373)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Valvular heart disease (including any valvular insufficiency or stenosis greater than"mild")
• Ablation within 3 months of study enrollment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (35)

Cardiology Consultants Of Orange County Med. Group Inc

Anaheim, California, 92801, United States

Location

Oracle Clinical Research, Inc.

Anaheim, California, 92801, United States

Location

Wcct Global, Llc

Costa Mesa, California, 92626, United States

Location

Long Beach Va Medical Center

Long Beach, California, 90822, United States

Location

Spectrum Clinical Research

Moreno Valley, California, 92553, United States

Location

Chase Medical Research, Llc

Waterbury, Connecticut, 06708, United States

Location

All Medical Research, Llc

Cooper City, Florida, 33024, United States

Location

The Cardiac And Vascular Institute Research Foundation, Llc

Gainesville, Florida, 32605, United States

Location

Acrc Cardiology

Lake Worth, Florida, 33462, United States

Location

The Heart Institute At Largo

Largo, Florida, 33770, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

Midwest Heart And Vascular Specialists, Llc.

Overland Park, Kansas, 66209, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

Castlerock Clinical Research Consultants, Llc

Tulsa, Oklahoma, 74136, United States

Location

Capital Area Research, Llc

Camp Hill, Pennsylvania, 17011, United States

Location

Tennessee Center For Clinical Trials

Tullahoma, Tennessee, 37388, United States

Location

Local Institution

Austin, Texas, 78705, United States

Location

Local Institution

Austin, Texas, United States

Location

Utah Cardiology P.C

Layton, Utah, 84041, United States

Location

Local Institution

Edmonton, Alberta, T6G 2B7, Canada

Location

Fraser Clinical Trials Inc.

New Westminster, British Columbia, V3L 3W4, Canada

Location

Local Institution

Cambridge, Ontario, N1R 7R1, Canada

Location

Dr. Andy S.C. Lam Medicine Professional

Grimsby, Ontario, L3M 1P3, Canada

Location

Stroke Prevention & Artherosclerosis Research Centre

London, Ontario, N6G 2V4, Canada

Location

Local Institution

Newmarket, Ontario, Canada

Location

Local Institution

Oshawa, Ontario, L1J 2J9, Canada

Location

King Street Cardiology

Oshawa, Ontario, L1J 2K1, Canada

Location

Local Institution

Toronto, Ontario, M3M 3E5, Canada

Location

Local Institution

Waterloo, Ontario, N2T 0C1, Canada

Location

Viacar Recherche Clinique

Greenfield Park, Quebec, J4V 2G8, Canada

Location

Local Institution

Montreal, Quebec, H1T 1C8, Canada

Location

Local Institution

Montreal, Quebec, H2W 1T8, Canada

Location

Local Institution

Québec, Quebec, G1V 4G5, Canada

Location

Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur

Terrebonne, Quebec, J6V 2H2, Canada

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Sponsor decided to terminate development of BMS-919373 for business reasons unrelated to safety, due to which data was not analyzed for maximum outcome measures.

Results Point of Contact

• Title: Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: June 5, 2014
• Study Start: July 25, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 31, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-07

Locations

US (20); CA (15)