Effects of Rosuvastatin on Aortic Stenosis Progression (NCT00800800) | Clinical Trial Compass
CompletedPhase 3
Effects of Rosuvastatin on Aortic Stenosis Progression
Canada378 participantsStarted 2002-11
Plain-language summary
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
Who can participate
Age range
18 Years – 82 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec
* Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines
* Baseline triglyceride levels must be within target level for the risk categories
Exclusion Criteria:
* Very mild AS defined by peak Doppler AS velocity \<2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception.
* Severe AS defined by peak Doppler AS velocity \> 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
* Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio \>0.45; Patients with diabetes or with a fasting blood sugar level \> 7.0 mmol/L (must be confirmed with one repeat assay within 14 days).
* Significant concomitant mitral valve disease, defined by \> moderate mitral regurgitation (MR) or mitral valve area (MVA)\< 1.5 cm2; A very high risk of CAD (10 year risk \> 30%), according to the Canadian Guidelines.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The changes in transvalvular aortic velocities and the changes in aortic valve area.
Timeframe: Between baseline and close-out measurments.