ArrhythmiaPhase 2NCT01396226
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
A Phase 2 study testing AZD2927 in people with Arrhythmia, run by AstraZeneca at 5 sites in 2 countries.
Trial summary
Medical Products Agency Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- AZD2927
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or postmenopausal female, aged 20 to 80 years inclusive,
- clinical indication for catheter ablation of atrial flutter,
- history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
- sinus rhythm at randomisation,
- adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,
Who cannot join
- cardioversion within 14 days before randomisation,
- history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
- QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,
- history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
- personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden4 sites
Research Site
Linköping
Research Site
Örebro
Research Site
Stockholm
Research Site
Umeå
About this study
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure
Medical Products Agency
Read the detailed description
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
- The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.
- Conditions
- Arrhythmia
- Being tested
- AZD2927, Placebo
- Keywords
- Atrial refractoriness, cardiac electrophysiology, IKACh
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2927Drug
A single dose of AZD2927 administered as an iv infusion
PlaceboDrug
A single dose of placebo administered as an iv infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A single dose of AZD2927 administered as an iv infusion Receives: Drug: AZD2927 |
| 2 | Placebo comparator | A single dose of placebo administered as an iv infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Atrial Effective Refractory Period
Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion
Measured: Baseline to last assessment during IP infusion
Secondary outcomes (9)
Ventricular Effective Refractory Period
Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion
Measured: Baseline to last assessment during IP infusion
Paced QT Interval
Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements
Measured: Baseline to last assessment during IP infusion
Atrio-ventricular Effective Refractory Period
Change from observation before IP infusion to during 1st and 2nd LAERP Mean
Measured: Baseline to last assessment during IP infusion
PA Interval
Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start
Measured: Baseline to last assessment during IP infusion
AH Interval
Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.
Measured: Baseline to last assessment during IP infusion
HV Interval
Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.
Measured: Baseline to last assessment during IP infusion
PR Interval
Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Measured: Baseline to last assessment during IP infusion
QRS Duration
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Measured: Baseline to last assessment during IP infusion
RR Interval
Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion
Measured: Baseline to last assessment during IP infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan C Carlsson, MD, PHD, Study director, AstraZenecaHakan Walfridsson, MD, PHD, Principal investigator, University Hospital Linkoping Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396226
- Sponsor's protocol ID
- D4120C00002
- Other IDs
- 2011-001716-59
- Status last verified
- Nov 2012
- First submitted
- 13 Jul 2011
- Last updated
- 27 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure
- ClinicalTrials.gov ID
- NCT01396226
- Acronym / sponsor ID
- D4120C00002
- Conditions
- Arrhythmia
- Keywords
- Atrial refractoriness, cardiac electrophysiology, IKACh
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 23 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical Products Agency
Detailed description
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
- The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2927A single dose of AZD2927 administered as an iv infusion |
| 2 | Placebo comparator | Drug: PlaceboA single dose of placebo administered as an iv infusion |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or postmenopausal female, aged 20 to 80 years inclusive,
- clinical indication for catheter ablation of atrial flutter,
- history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
- sinus rhythm at randomisation,
- adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,
Key exclusion criteria (5 listed)
- cardioversion within 14 days before randomisation,
- history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
- QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,
- history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
- personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia.
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 |
|---|---|---|
| AZD2927A single dose of AZD2927 administered as an iv infusion | Drug | 1 |
| PlaceboA single dose of placebo administered as an iv infusion | Drug | 2 |
Primary outcome
Left Atrial Effective Refractory Period
Time frame: Baseline to last assessment during IP infusion
Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion
9 secondary outcomes
Ventricular Effective Refractory Period
Time frame: Baseline to last assessment during IP infusion
Paced QT Interval
Time frame: Baseline to last assessment during IP infusion
Atrio-ventricular Effective Refractory Period
Time frame: Baseline to last assessment during IP infusion
PA Interval
Time frame: Baseline to last assessment during IP infusion
AH Interval
Time frame: Baseline to last assessment during IP infusion
HV Interval
Time frame: Baseline to last assessment during IP infusion
PR Interval
Time frame: Baseline to last assessment during IP infusion
QRS Duration
Time frame: Baseline to last assessment during IP infusion
RR Interval
Time frame: Baseline to last assessment during IP infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stefan C Carlsson, MD, PHD study director
AstraZeneca
Hakan Walfridsson, MD, PHD principal investigator
University Hospital Linkoping Sweden
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2927 in people with Arrhythmia, run by AstraZeneca at 5 sites in 2 countries.
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 5 inclusion and 5 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Norway. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Left Atrial Effective Refractory Period (time frame: Baseline to last assessment during IP infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2012.