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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356914
• Other study ID #: CV203-010
• Secondary ID: 2010-022947-39
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2011
• Last updated: September 23, 2015
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• BMS-914392
Tablets, Oral, 10 mg, Every Day (QD), 20 days
• BMS-914392
Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days
• BMS-914392
Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days
• Placebo
Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days

Locations

Country	Name	City	State
United Kingdom	Eastbourne General Hospital	Eastbourne

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation Burden		At screening (baseline)	No
Primary	Atrial Fibrillation Burden		Prior to randomization to study drug	No
Primary	Atrial Fibrillation Burden		On Day 1 of each cross-over period	No
Primary	Atrial Fibrillation Burden		On Day 8 of each cross-over period	No
Primary	Atrial Fibrillation Burden		On Day 22 of each cross-over period	No
Secondary	Number of participants with adverse events and type of adverse events		At Day 1 of each cross-over period	No
Secondary	Number of participants with adverse events and type of adverse events		At Day 8 of each cross-over period	No
Secondary	Number of participants with adverse events and type of adverse events		At Day 22 of each cross-over period	No
Secondary	Number of Atrial fibrillation (AF) episodes		At Day 1 of each cross-over period	No
Secondary	Number of AF episodes		At Day 8 of each cross-over period	No
Secondary	Number of AF episodes		At Day 22 of each cross-over period	No
Secondary	Duration of AF episodes		At Day 1 of each cross-over period	No
Secondary	Duration of AF episodes		At Day 8 of each cross-over period	No
Secondary	Duration of AF episodes		At Day 22 of each cross-over period	No
Secondary	Heart Rate		At Day 1 of each cross-over period	No
Secondary	Heart Rate		At Day 8 of each cross-over period	No
Secondary	Heart Rate		At Day 22 of each cross-over period	No
Secondary	Severity of AF (SAF) scale score at the end of each study period		At Day 1 of each cross-over period	No
Secondary	Severity of AF (SAF) scale score at the end of each study period		At Day 8 of each cross-over period	No
Secondary	Severity of AF (SAF) scale score at the end of each study period		At Day 22 of each cross-over period	No
Secondary	Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)		At Day 1 of each cross-over period	No
Secondary	Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)		At Day 8 of each cross-over period	No
Secondary	Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)		At Day 22 of each cross-over period	No
Secondary	BMS-914392 plasma concentrations and exposures during each study period		At Days 1, 8 and 22 of each cross-over period	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm