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Paroxysmal Atrial FibrillationPhase 2NCT02156076

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

A Phase 2 study testing BMS-919373 in people with Paroxysmal Atrial Fibrillation, run by Bristol-Myers Squibb at 35 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
BMS-919373
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
35 sitesin 2 countries
Study dates
25 Jul 2014to 1 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States20 sites

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301

  • Cardiology Consultants Of Orange County Med. Group Inc

    Anaheim, California, 92801

  • Oracle Clinical Research, Inc.

    Anaheim, California, 92801

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Local Institution

    Austin, Texas, 78705

  • Local Institution

    Austin, Texas

  • Capital Area Research, Llc

    Camp Hill, Pennsylvania, 17011

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • All Medical Research, Llc

    Cooper City, Florida, 33024

  • Wcct Global, Llc

    Costa Mesa, California, 92626

  • The Cardiac And Vascular Institute Research Foundation, Llc

    Gainesville, Florida, 32605

  • Acrc Cardiology

    Lake Worth, Florida, 33462

  • The Heart Institute At Largo

    Largo, Florida, 33770

  • Utah Cardiology P.C

    Layton, Utah, 84041

  • Long Beach Va Medical Center

    Long Beach, California, 90822

  • Spectrum Clinical Research

    Moreno Valley, California, 92553

  • Midwest Heart And Vascular Specialists, Llc.

    Overland Park, Kansas, 66209

  • Tennessee Center For Clinical Trials

    Tullahoma, Tennessee, 37388

  • Castlerock Clinical Research Consultants, Llc

    Tulsa, Oklahoma, 74136

  • Chase Medical Research, Llc

    Waterbury, Connecticut, 06708

Other trials in United States

Canada15 sites

  • Local Institution

    Cambridge, Ontario, N1R 7R1

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Viacar Recherche Clinique

    Greenfield Park, Quebec, J4V 2G8

  • Dr. Andy S.C. Lam Medicine Professional

    Grimsby, Ontario, L3M 1P3

  • Stroke Prevention & Artherosclerosis Research Centre

    London, Ontario, N6G 2V4

  • Local Institution

    Montreal, Quebec, H1T 1C8

  • Local Institution

    Montreal, Quebec, H2W 1T8

  • Fraser Clinical Trials Inc.

    New Westminster, British Columbia, V3L 3W4

  • Local Institution

    Newmarket, Ontario

  • Local Institution

    Oshawa, Ontario, L1J 2J9

  • King Street Cardiology

    Oshawa, Ontario, L1J 2K1

  • Local Institution

    Québec, Quebec, G1V 4G5

  • Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur

    Terrebonne, Quebec, J6V 2H2

  • Local Institution

    Toronto, Ontario, M3M 3E5

  • Local Institution

    Waterloo, Ontario, N2T 0C1

Other trials in Canada

About this study

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

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.

Read the detailed 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.

Being tested
BMS-919373, Placebo (Matching with BMS-919373)
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-919373Drug

  • Placebo (Matching with BMS-919373)Drug

Study groups in NCT02156076
Study groupRoleWhat they receive
Arm A: Placebo (Matching with BMS-919373)Placebo comparatorPlacebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
Receives: Drug: Placebo (Matching with BMS-919373)
Arm B: BMS-919373ExperimentalBMS-919373 3 mg tablets orally once daily for approximately 28 days
Receives: Drug: BMS-919373
Arm C: BMS-919373ExperimentalBMS-919373 5 mg tablets orally once daily for approximately 28 days
Receives: Drug: BMS-919373
Arm D: BMS-919373ExperimentalBMS-919373 12 mg tablets orally once daily for approximately 28 days
Receives: Drug: BMS-919373

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 8 to Day 29

Secondary outcomes (11)

  1. 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.

    Measured: Up to Day 50

  2. Maximum Observed Concentarion (Cmax) of BMS-919373

    Cmax is defined as the maximum observed concentration of BMS-919373.

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

  3. Trough Observed Concentration (Cmin) of BMS-919373

    Ctrough is defined as the minimum estimated plasma concentration at steady state.

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

  4. 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.

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

  5. 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.

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

  6. Absorption Rate Constant (Ka) of BMS-919373

    Ka is the absorption rate constant.

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

  7. Average Concentration (Cavg) of BMS-919373 at Steady State

    Cavg is defines as the average concentration at steady state.

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

  8. 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.

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

  9. 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.

    Measured: Day 8 to Day 29

  10. Total Number of Atrial Fibrillation Episodes

    The total number AF episodes were derived from AF episode histogram data over the monitoring period.

    Measured: Day 8 to Day 29

  11. 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.

    Measured: Day 8 to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2014 (estimated)
  2. Study start25 Jul 2014
  3. Primary completion1 Jun 2016
  4. Study completion1 Jun 2016

Why it stopped: Sponsor decision based on business reasons, unrelated to safety

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156076
Sponsor's protocol ID
CV205-005
Status last verified
Jul 2019
First submitted
12 May 2014
Last updated
31 Jul 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-919373 in people with Paroxysmal Atrial Fibrillation, run by Bristol-Myers Squibb at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System (time frame: Day 8 to Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.

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