Heart Valve DiseasesPhase 3NCT02084069
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
A Phase 3 study testing Atorvastatin in people with Heart Valve Diseases, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 3
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 25 y/o
- No occurrence of intra- or post-operative cardiopulmonary arrest
- Not consuming drugs affecting atrial rhythm
- Having sinus rhythm before surgery
- Lack of paroxysmal atrial fibrillation history
- Only undergo heart valve surgery
- Lack of considerable heart ischemia needed atorvastatin use
- Routine cares in ward, post-operative ward, and intensive care unit were done
Who cannot join
- Lesser than 25 y/o
- History of atrial fibrillation
- History of taking anti-arrhythmic drugs
- History of implementing pacemakers
- Severe heart failure
- Renal failure
Show all 12Show fewer
- Hepatic failure
- Severe pulmonary diseases
- Heart block or bradyarrhythmia
- Routine cares in ward, post-operative ward, and intensive care unit were not done
- Performing concomitant cardiac surgery except valve repair
- Having considerable heart ischemia needed atorvastatin use
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.
- Conditions
- Heart Valve Diseases
- Being tested
- Atorvastatin
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery Receives: Drug: Atorvastatin |
| Control | Placebo comparator | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Incidence After Open Cardiac Valve Repair
Measured: Within 5 days after open cardiac valve repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yousef Rezaei, M.D, Study director, Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084069
- Sponsor's protocol ID
- UMSU-Cardiology-2
- Status last verified
- Feb 2015
- First submitted
- 8 Mar 2014
- Last updated
- 4 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24.
PubMed 25540059
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
- ClinicalTrials.gov ID
- NCT02084069
- Acronym / sponsor ID
- UMSU-Cardiology-2
- Conditions
- Heart Valve Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 4 Feb 2015
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 investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: AtorvastatinAtorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery |
| Control | Placebo comparator | –Placebo |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Greater than 25 y/o
- No occurrence of intra- or post-operative cardiopulmonary arrest
- Not consuming drugs affecting atrial rhythm
- Having sinus rhythm before surgery
- Lack of paroxysmal atrial fibrillation history
Key exclusion criteria (12 listed)
- Lesser than 25 y/o
- History of atrial fibrillation
- History of taking anti-arrhythmic drugs
- History of implementing pacemakers
- Severe heart failure
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 |
|---|---|---|
| Atorvastatin | Drug | Treatment |
Primary outcome
Atrial Fibrillation Incidence After Open Cardiac Valve Repair
Time frame: Within 5 days after open cardiac valve repair
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25540059Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24.
- Related InfoLink provided by the sponsor.
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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.
Yousef Rezaei, M.D study director
Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Heart Valve Diseases, run by Urmia University of Medical Sciences at 1 site in Iran.
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 8 inclusion and 12 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 4 Mar 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Feb 2015). 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?
Atrial Fibrillation Incidence After Open Cardiac Valve Repair (time frame: Within 5 days after open cardiac valve repair). 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 NCT02084069, 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 4 Mar 2015.