NCT01356914

Brief Summary

The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

April 15, 2011

Last Update Submit

September 23, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

  • Atrial Fibrillation Burden

    At screening (baseline)

  • Atrial Fibrillation Burden

    Prior to randomization to study drug

  • Atrial Fibrillation Burden

    On Day 1 of each cross-over period

  • Atrial Fibrillation Burden

    On Day 8 of each cross-over period

  • Atrial Fibrillation Burden

    On Day 22 of each cross-over period

Secondary Outcomes (19)

  • Number of participants with adverse events and type of adverse events

    At Day 1 of each cross-over period

  • Number of participants with adverse events and type of adverse events

    At Day 8 of each cross-over period

  • Number of participants with adverse events and type of adverse events

    At Day 22 of each cross-over period

  • Number of Atrial fibrillation (AF) episodes

    At Day 1 of each cross-over period

  • Number of AF episodes

    At Day 8 of each cross-over period

  • +14 more secondary outcomes

Study Arms (4)

Treatment A: BMS-914392

EXPERIMENTAL
Drug: BMS-914392

Treatment B: BMS-914392

EXPERIMENTAL
Drug: BMS-914392

Treatment C: BMS-914392

EXPERIMENTAL
Drug: BMS-914392

Treatment D: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-914392DRUG

Tablets, Oral, 10 mg, Every Day (QD), 20 days

Treatment A: BMS-914392
PlaceboDRUG

Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days

Treatment D: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal atrial fibrillation (AF)
  • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
  • % AF burden on pacemaker interrogation at screening.
  • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.

You may not qualify if:

  • Persistent or permanent AF.
  • AF Burden \<1% or \> 50%.
  • Current or history of neurological diseases and mental disorders.
  • Ejection Fraction \< 45%.
  • Severe mitral or aortic valve dysfunction.
  • TIA (Transient Ischemic Attack) within last 12 months.
  • Acute coronary syndrome in the last 2 months.
  • Previous AF ablation.
  • Cardioversion in last 3 months.
  • Current kidney or liver disease, or current cancer.
  • History of neurological and mental disorders.
  • Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
  • Screening lab test results outside of allowed limits per protocol.
  • QTcF \> 450 msec.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastbourne General Hospital

Eastbourne, BN21 2UD, United Kingdom

Location

Related Publications (1)

  • Podd SJ, Freemantle N, Furniss SS, Sulke N. First clinical trial of specific IKACh blocker shows no reduction in atrial fibrillation burden in patients with paroxysmal atrial fibrillation: pacemaker assessment of BMS 914392 in patients with paroxysmal atrial fibrillation. Europace. 2016 Mar;18(3):340-6. doi: 10.1093/europace/euv263. Epub 2015 Oct 12.

    PMID: 26462707DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

May 20, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

GB(1)