Atrial FibrillationPhase 2PAFRIOSIESNCT00321802
Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
A Phase 2 study testing Simvastatin in people with Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal AF (> 3 epis each > 15 min in length) over 6 months
- Patients on stable antiarrhythmic drug therapy and life expectancy > 1 year
Who cannot join
- Patients with PAF due to reversible cause
- Chronic inflammatory conditions
- Other medical conditions requiring statin therapy
- Patients on amiodarone or verapamil
- Elevated CK or ALT
- Life expectancy <1 year
Show all 9Show fewer
- TAVN ablation
- Geographic isolation
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary, Foothills Hospital
Calgary, Alberta, T2N 4N1
About this study
The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.
Read the detailed description
Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.
Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.
Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.
Clinic visits are required at randomization, 3 months and 6 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Simvastatin, Placebo
- Keywords
- atrial fibrillation, statin therapy, CRP levels, Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
Patients take 40 mg of simvastatin per day for 6 months.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm. Receives: Drug: Simvastatin |
| 2 | Placebo comparator | Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first detected AF
Measured: 6 Months
Secondary outcomes (1)
Changes in CRP and oxidative stress levels over time and their relationship with AF burden
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Anne M. Gillis, University of Calgary
- Investigators
- Anne M Gillis, MD, Principal investigator, University of CalgaryHenry J Duff, MD, Study director, University of CalgaryDerek V Exner, MD, MPH, Study director, University of CalgaryKatherine Kavanagh, MD, Study director, University of CalgaryL B Mitchell, MD, Study director, University of CalgaryRobert S Sheldon, MD, PhD, Study director, University of CalgaryD G Wyse, MD, PhD, Study director, University of CalgaryGeorge Veenhuyzen, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321802
- Sponsor's protocol ID
- 18108
- Acronym
- PAFRIOSIES
- Status last verified
- Dec 2014
- First submitted
- 3 May 2006
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
- ClinicalTrials.gov ID
- NCT00321802
- Acronym / sponsor ID
- PAFRIOSIES / 18108
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, statin therapy, CRP levels, Paroxysmal Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 May 2006 (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 determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.
Detailed description
Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.
Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.
Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.
Clinic visits are required at randomization, 3 months and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SimvastatinPatients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm. |
| 2 | Placebo comparator | Drug: PlaceboPatients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with paroxysmal AF (> 3 epis each > 15 min in length) over 6 months
- Patients on stable antiarrhythmic drug therapy and life expectancy > 1 year
Key exclusion criteria (9 listed)
- Patients with PAF due to reversible cause
- Chronic inflammatory conditions
- Other medical conditions requiring statin therapy
- Patients on amiodarone or verapamil
- Elevated CK or ALT
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 |
|---|---|---|
| SimvastatinAlso: ZocorPatients take 40 mg of simvastatin per day for 6 months. | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Time to first detected AF
Time frame: 6 Months
1 secondary outcome
Changes in CRP and oxidative stress levels over time and their relationship with AF burden
Time frame: 6 Months
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 1 Jan 2015.
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Atrial Fibrillation (AF)
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.
Anne M Gillis, MD principal investigator
University of Calgary
Henry J Duff, MD study director
University of Calgary
Derek V Exner, MD, MPH study director
University of Calgary
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 Simvastatin in people with Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 9 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 1 Jan 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 Canada. 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?
Time to first detected AF (time frame: 6 Months). 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 1 Jan 2015.