Paroxysmal Atrial FibrillationPhase 2ASETNCT01710852
Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation
A Phase 2 study testing ISIS CRP Rx in people with Paroxysmal Atrial Fibrillation, run by Ionis Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- ISIS CRP Rx
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Apr 2014
- 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
- Male of female; age over 18 years
- Dual chamber permanent pacemaker implanted
- Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms
- Able to have pacemaker antiarrhythmic algorithms turned off for the duration of the study
- Able to discontinue all Class I and III antiarrhythmic medication for the duration of the study
- Therapeutically anticoagulated with warfarin or dabigatran, and anticipated to be for duration of the study
- High sensitivity C-Reactive Protein (hsCRP) between 2 and 10 mg/L (inclusive)
Who cannot join
- Clinically significant abnormalities in medical history, physical examination, or screening laboratory results that would render a subject unsuitable for inclusion
- NYHA class III/IV heart failure
- Impaired left ventricular function of less than 45% determined by echocardiography within 3 months of screening
- Moderate or greater mitral regurgitation assessed by echocardiography within 3 months of screening
- Permanent AF
- Continuous Amiodarone therapy within 90 days prior to Study Day 1
Show all 11Show fewer
- Treatment with another Study Drug, biological agent, or device within one-month of screening, or five half-lives of study agent, whichever is longer
- Use of systemic corticosteroids or other anti-inflammatory medications including non-steroidal anti-inflammatory drugs (NSAIDs)
- Use of statins, ACE inhibitors or AT-receptor antagonists unless on a stable regimen for at least 3 months prior to dosing and will remain on a stable regimen for the duration of the study
- Uncontrolled hypertension (BP >160/100)
- Current or expected use of any anticoagulant apart from warfarin or dabigatran
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eastbourne General Hospital - Cardiology Department
Eastbourne, East Sussex, BN21 2UD
About this study
Official title: A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- ISIS CRP Rx, Placebo
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS CRP RxDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | ISIS CRP Rx followed by Placebo Receives: Drug: ISIS CRP Rx; Drug: Placebo |
| Group B | Experimental | Placebo followed by ISIS CRP Rx Receives: Drug: ISIS CRP Rx; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden reduction
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
Measured: 113 Days
Secondary outcomes (7)
To assess the effect of ISIS CRP Rx on the:
- total number of AF episodes
- average duration of AF per episode
- average sinus rhythm duration
- atrial and ventricular rate during AF episodes
Measured: 113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
Measured: 113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
Measured: 113 Days
To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF
Change from Baseline will be compared for each treatment period
Measured: 113 Days
To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF
Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group.
Measured: 113 Days
To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF
Incidence rates of all Adverse Events will be tabulated by MedRA system Organ Class and by MedRA Term for each treatment group. Lab Tests, Vital Signs, And ECG Parameters will be summarized by study visit for each treatment group.
Measured: 113 Days
To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF
Trough levels of ISIS CRP Rx will be assessed at intervals throughout the study
Measured: 113 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710852
- Sponsor's protocol ID
- ISIS 329993-CS6
- Acronym
- ASET
- Status last verified
- Aug 2015
- First submitted
- 9 Oct 2012
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01710852
- Acronym / sponsor ID
- ASET / ISIS 329993-CS6
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, AF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Oct 2012 (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 this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ISIS CRP Rx, Drug: PlaceboISIS CRP Rx followed by Placebo |
| Group B | Experimental | Drug: ISIS CRP Rx, Drug: PlaceboPlacebo followed by ISIS CRP Rx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male of female; age over 18 years
- Dual chamber permanent pacemaker implanted
- Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms
- Able to have pacemaker antiarrhythmic algorithms turned off for the duration of the study
- Able to discontinue all Class I and III antiarrhythmic medication for the duration of the study
Key exclusion criteria (11 listed)
- Clinically significant abnormalities in medical history, physical examination, or screening laboratory results that would render a subject unsuitable for inclusion
- NYHA class III/IV heart failure
- Impaired left ventricular function of less than 45% determined by echocardiography within 3 months of screening
- Moderate or greater mitral regurgitation assessed by echocardiography within 3 months of screening
- Permanent AF
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 |
|---|---|---|
| ISIS CRP Rx | Drug | Group A, Group B |
| Placebo | Drug | Group A, Group B |
Primary outcome
AF burden reduction
Time frame: 113 Days
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
7 secondary outcomes
To assess the effect of ISIS CRP Rx on the:
Time frame: 113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
Time frame: 113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
Time frame: 113 Days
To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF
Time frame: 113 Days
To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF
Time frame: 113 Days
To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF
Time frame: 113 Days
To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF
Time frame: 113 Days
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 26 Aug 2015.
Related trials for Paroxysmal Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ISIS CRP Rx in people with Paroxysmal Atrial Fibrillation, run by Ionis Pharmaceuticals, Inc. 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 7 inclusion and 11 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 26 Aug 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. 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?
AF burden reduction (time frame: 113 Days). 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 26 Aug 2015.