Atrial FibrillationPhase 2NCT01356914
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden
A Phase 2 study testing BMS-914392 in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- BMS-914392
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- BMS-914392, Placebo
- 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-914392Drug
Tablets, Oral, 10 mg, Every Day (QD), 20 days
BMS-914392Drug
Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days
BMS-914392Drug
Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days
PlaceboDrug
Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-914392 | Experimental | Not described Receives: Drug: BMS-914392 |
| Treatment B: BMS-914392 | Experimental | Not described Receives: Drug: BMS-914392 |
| Treatment C: BMS-914392 | Experimental | Not described Receives: Drug: BMS-914392 |
| Treatment D: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Burden
Measured: At screening (baseline)
Atrial Fibrillation Burden
Measured: Prior to randomization to study drug
Atrial Fibrillation Burden
Measured: On Day 1 of each cross-over period
Atrial Fibrillation Burden
Measured: On Day 8 of each cross-over period
Atrial Fibrillation Burden
Measured: On Day 22 of each cross-over period
Secondary outcomes (19)
Number of participants with adverse events and type of adverse events
Measured: At Day 1 of each cross-over period
Number of participants with adverse events and type of adverse events
Measured: At Day 8 of each cross-over period
Number of participants with adverse events and type of adverse events
Measured: At Day 22 of each cross-over period
Number of Atrial fibrillation (AF) episodes
Measured: At Day 1 of each cross-over period
Number of AF episodes
Measured: At Day 8 of each cross-over period
Number of AF episodes
Measured: At Day 22 of each cross-over period
Duration of AF episodes
Measured: At Day 1 of each cross-over period
Duration of AF episodes
Measured: At Day 8 of each cross-over period
Duration of AF episodes
Measured: At Day 22 of each cross-over period
Heart Rate
Measured: At Day 1 of each cross-over period
Heart Rate
Measured: At Day 8 of each cross-over period
Heart Rate
Measured: At Day 22 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Measured: At Day 1 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Measured: At Day 8 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Measured: At Day 22 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Measured: At Day 1 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Measured: At Day 8 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Measured: At Day 22 of each cross-over period
BMS-914392 plasma concentrations and exposures during each study period
Measured: At Days 1, 8 and 22 of each cross-over period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356914
- Sponsor's protocol ID
- CV203-010
- Other IDs
- 2010-022947-39
- Status last verified
- Sep 2015
- First submitted
- 15 Apr 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26462707
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01356914
- Acronym / sponsor ID
- CV203-010
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-914392Tablets, Oral, 10 mg, Every Day (QD), 20 days | Drug | Treatment A: BMS-914392 |
| BMS-914392Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days | Drug | Treatment B: BMS-914392 |
| BMS-914392Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days | Drug | Treatment C: BMS-914392 |
| PlaceboTablets, Oral, 0 mg, Three Times Daily (TID), 20 days | Drug | Treatment D: Placebo |
Primary outcome
Atrial Fibrillation Burden
Time frame: At screening (baseline)
Atrial Fibrillation Burden
Time frame: Prior to randomization to study drug
Atrial Fibrillation Burden
Time frame: On Day 1 of each cross-over period
Atrial Fibrillation Burden
Time frame: On Day 8 of each cross-over period
Atrial Fibrillation Burden
Time frame: On Day 22 of each cross-over period
19 secondary outcomes
Number of participants with adverse events and type of adverse events
Time frame: At Day 1 of each cross-over period
Number of participants with adverse events and type of adverse events
Time frame: At Day 8 of each cross-over period
Number of participants with adverse events and type of adverse events
Time frame: At Day 22 of each cross-over period
Number of Atrial fibrillation (AF) episodes
Time frame: At Day 1 of each cross-over period
Number of AF episodes
Time frame: At Day 8 of each cross-over period
Number of AF episodes
Time frame: At Day 22 of each cross-over period
Duration of AF episodes
Time frame: At Day 1 of each cross-over period
Duration of AF episodes
Time frame: At Day 8 of each cross-over period
Duration of AF episodes
Time frame: At Day 22 of each cross-over period
Heart Rate
Time frame: At Day 1 of each cross-over period
Heart Rate
Time frame: At Day 8 of each cross-over period
Heart Rate
Time frame: At Day 22 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Time frame: At Day 1 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Time frame: At Day 8 of each cross-over period
Severity of AF (SAF) scale score at the end of each study period
Time frame: At Day 22 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Time frame: At Day 1 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Time frame: At Day 8 of each cross-over period
Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)
Time frame: At Day 22 of each cross-over period
BMS-914392 plasma concentrations and exposures during each study period
Time frame: At Days 1, 8 and 22 of each cross-over period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 26462707Podd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-914392 in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Atrial Fibrillation Burden (time frame: At screening (baseline)). The study lists 5 primary outcomes in all. 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 NCT01356914, which also lists 1 linked publication.
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 12 Oct 2015.