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Completed

NCT Number: NCT01356914

Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eastbourne General Hospital

Eastbourne, BN21 2UD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Paroxysmal atrial fibrillation (AF)
  • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
  • 1-50% 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.

Exclusion criteria

  • 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.

Treatment and study plan

BMS-914392

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Atrial Fibrillation Burden

    Time frame: At screening (baseline)

  2. Atrial Fibrillation Burden

    Time frame: Prior to randomization to study drug

  3. Atrial Fibrillation Burden

    Time frame: On Day 1 of each cross-over period

  4. Atrial Fibrillation Burden

    Time frame: On Day 8 of each cross-over period

  5. Atrial Fibrillation Burden

    Time frame: On Day 22 of each cross-over period

Secondary outcomes

  1. Number of participants with adverse events and type of adverse events

    Time frame: At Day 1 of each cross-over period

  2. Number of participants with adverse events and type of adverse events

    Time frame: At Day 8 of each cross-over period

  3. Number of participants with adverse events and type of adverse events

    Time frame: At Day 22 of each cross-over period

  4. Number of Atrial fibrillation (AF) episodes

    Time frame: At Day 1 of each cross-over period

  5. Number of AF episodes

    Time frame: At Day 8 of each cross-over period

  6. Number of AF episodes

    Time frame: At Day 22 of each cross-over period

  7. Duration of AF episodes

    Time frame: At Day 1 of each cross-over period

  8. Duration of AF episodes

    Time frame: At Day 8 of each cross-over period

  9. Duration of AF episodes

    Time frame: At Day 22 of each cross-over period

  10. Heart Rate

    Time frame: At Day 1 of each cross-over period

  11. Heart Rate

    Time frame: At Day 8 of each cross-over period

  12. Heart Rate

    Time frame: At Day 22 of each cross-over period

  13. Severity of AF (SAF) scale score at the end of each study period

    Time frame: At Day 1 of each cross-over period

  14. Severity of AF (SAF) scale score at the end of each study period

    Time frame: At Day 8 of each cross-over period

  15. Severity of AF (SAF) scale score at the end of each study period

    Time frame: At Day 22 of each cross-over period

  16. Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)

    Time frame: At Day 1 of each cross-over period

  17. Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)

    Time frame: At Day 8 of each cross-over period

  18. Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)

    Time frame: At Day 22 of each cross-over period

  19. BMS-914392 plasma concentrations and exposures during each study period

    Time frame: At Days 1, 8 and 22 of each cross-over period

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients With Paroxysmal Atrial Fibrillation and Permanent Pacemaker

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 20, 2011
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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