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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

BMS-914392

Placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Eastbourne General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment A: BMS-914392

Treatment B: BMS-914392

Treatment C: BMS-914392

Treatment D: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Atrial Fibrillation Burden

Secondary Outcome Measures

Number of participants with adverse events and type of adverse events

Number of Atrial fibrillation (AF) episodes

Number of AF episodes

Duration of AF episodes

Heart Rate

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

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

BMS-914392 plasma concentrations and exposures during each study period

Full Information

NCT ID

NCT01356914

First Posted

April 15, 2011

Last Updated

September 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01356914

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A: BMS-914392

Arm Type

Experimental

Arm Title

Treatment B: BMS-914392

Arm Type

Experimental

Arm Title

Treatment C: BMS-914392

Arm Type

Experimental

Arm Title

Treatment D: Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BMS-914392

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BMS-914392

Intervention Description

Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days

Intervention Type

Drug

Intervention Name(s)

BMS-914392

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Atrial Fibrillation Burden

Time Frame

At screening (baseline)

Title

Atrial Fibrillation Burden

Time Frame

Prior to randomization to study drug

Title

Atrial Fibrillation Burden

Time Frame

On Day 1 of each cross-over period

Title

Atrial Fibrillation Burden

Time Frame

On Day 8 of each cross-over period

Title

Atrial Fibrillation Burden

Time Frame

On Day 22 of each cross-over period

Secondary Outcome Measure Information:

Title

Number of participants with adverse events and type of adverse events

Time Frame

At Day 1 of each cross-over period

Title

Number of participants with adverse events and type of adverse events

Time Frame

At Day 8 of each cross-over period

Title

Number of participants with adverse events and type of adverse events

Time Frame

At Day 22 of each cross-over period

Title

Number of Atrial fibrillation (AF) episodes

Time Frame

At Day 1 of each cross-over period

Title

Number of AF episodes

Time Frame

At Day 8 of each cross-over period

Title

Number of AF episodes

Time Frame

At Day 22 of each cross-over period

Title

Duration of AF episodes

Time Frame

At Day 1 of each cross-over period

Title

Duration of AF episodes

Time Frame

At Day 8 of each cross-over period

Title

Duration of AF episodes

Time Frame

At Day 22 of each cross-over period

Title

Heart Rate

Time Frame

At Day 1 of each cross-over period

Title

Heart Rate

Time Frame

At Day 8 of each cross-over period

Title

Heart Rate

Time Frame

At Day 22 of each cross-over period

Title

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

Time Frame

At Day 1 of each cross-over period

Title

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

Time Frame

At Day 8 of each cross-over period

Title

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

Time Frame

At Day 22 of each cross-over period

Title

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

Time Frame

At Day 1 of each cross-over period

Title

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

Time Frame

At Day 8 of each cross-over period

Title

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

Time Frame

At Day 22 of each cross-over period

Title

BMS-914392 plasma concentrations and exposures during each study period

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Eastbourne General Hospital

City

Eastbourne

ZIP/Postal Code

BN21 2UD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26462707

Citation

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.

Results Reference

derived

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

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