Valvular Cardiac SurgeryPhase 3NCT01425398
A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
A Phase 3 study testing Rosuvastatin in people with Valvular Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Cardiac Surgery
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 3
- 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
- Single or multiple valve repairs or replacements without coronary artery bypass grafting
- Bentall procedure, but no other aortic procedures
- With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)
Who cannot join
- Age under 18 years old
- Urgent or emergency surgery
- Unable to provide consent
- Presently on statin therapy or exposure to statins within a month of surgery
- Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
- Known hypersensitivity to rosuvastatin
Show all 12Show fewer
- Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
- Pregnant or nursing women
- On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
- Creatinine clearance < 30 ml/min/1.73 m2
- Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
- Human Immunodeficiency Virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
- Conditions
- Valvular Cardiac Surgery
- Being tested
- Rosuvastatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rosuvastatin 40 mg/day
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
PlaceboDrug
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Inflammatory Markers
Significant (p<0.05) improvement of measured inflammatory markers
Measured: Within 5 days post-op and at 3 months
Secondary outcomes (4)
Mortality
Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo
Measured: Within 3 months
Stroke
Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo
Measured: Within 3 months
Myocardial Infarction
Significant (p<0.05) reduction of MI events in rosuvastatin arm versus
Measured: Within 3 months
ICU length of stay
Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques Genest, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jacques Genest, MD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425398
- Sponsor's protocol ID
- statins_inflammation_CVsurgery
- Status last verified
- Oct 2021
- First submitted
- 26 Aug 2011
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT01425398
- Acronym / sponsor ID
- statins_inflammation_CVsurgery
- Conditions
- Valvular Cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 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.
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinRosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 tab qd x 5d before operation and then from post-op day 0 to 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single or multiple valve repairs or replacements without coronary artery bypass grafting
- Bentall procedure, but no other aortic procedures
- With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)
Key exclusion criteria (12 listed)
- Age under 18 years old
- Urgent or emergency surgery
- Unable to provide consent
- Presently on statin therapy or exposure to statins within a month of surgery
- Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
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 |
|---|---|---|
| RosuvastatinAlso: Rosuvastatin 40 mg/dayRosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. | Drug | Rosuvastatin |
| PlaceboPlacebo 1 tab qd x 5d before operation and then from post-op day 0 to 5. | Drug | Placebo |
Primary outcome
Improved Inflammatory Markers
Time frame: Within 5 days post-op and at 3 months
Significant (p<0.05) improvement of measured inflammatory markers
4 secondary outcomes
Mortality
Time frame: Within 3 months
Stroke
Time frame: Within 3 months
Myocardial Infarction
Time frame: Within 3 months
ICU length of stay
Time frame: 3 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 21 Oct 2021.
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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.
Jacques Genest, MD principal investigator
RI-MUHC
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 Rosuvastatin in people with Valvular Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 3 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 21 Oct 2021. 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 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?
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?
Improved Inflammatory Markers (time frame: Within 5 days post-op and at 3 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 21 Oct 2021.