Aortic StenosisPhase 3ASTRONOMERNCT00800800
Effects of Rosuvastatin on Aortic Stenosis Progression
A Phase 3 study testing Rosuvastatin in people with Aortic Stenosis, run by AstraZeneca at 15 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 15 sitesCanada
- Study dates
- Nov 2002to Sep 2008
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Research site
Brampton, Ontario
Research site
Calgary, Alberta
Research site
Cambridge, Ontario
Research site
Edmonton, Alberta
Research site
Edmonton, Manitoba
Research site
Halifax
Research site
Kitchener, Ontario
Research site
Montreal, Ontario
Research site
Montreal, Quebec
Research site
Ottawa, Ontario
Research site
St. John's
Research site
Surrey, British Columbia
Research site
Toronto, Ontario
Research site
Vancouver, British Columbia
Research site
Victoria, British Columbia
About this study
Official title: Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.
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.
- Conditions
- Aortic Stenosis
- Being tested
- Rosuvastatin, Placebo
- Keywords
- progression of aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
40 mg, oral, single dose
PlaceboDrug
oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rosuvastatin 40 mg Receives: Drug: Rosuvastatin |
| 2 | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in transvalvular aortic velocities and the changes in aortic valve area.
Measured: Between baseline and close-out measurments.
Secondary outcomes (2)
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Measured: Baseline and minimum of 3 year follow-up.
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Measured: Between baseline and close-out measurments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2002
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800800
- Sponsor's protocol ID
- DC-452-0003
- Acronym
- ASTRONOMER
- Status last verified
- Dec 2010
- First submitted
- 25 Nov 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Capoulade R, Torzewski M, Mayr M, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam J, Teo KK, Burnap SA, Schmid J, Gobel N, Franke UFW, Sanchez A, Witztum JL, Yang X, Yeang C, Arsenault B, Despres JP, Pibarot P, Tsimikas S. ApoCIII-Lp(a) complexes in conjunction with Lp(a)-OxPL predict rapid progression of aortic stenosis. Heart. 2020 May;106(10):738-745. doi: 10.1136/heartjnl-2019-315840. Epub 2020 Feb 13.
PubMed 32054669Capoulade R, Yeang C, Chan KL, Pibarot P, Tsimikas S. Association of Mild to Moderate Aortic Valve Stenosis Progression With Higher Lipoprotein(a) and Oxidized Phospholipid Levels: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2018 Dec 1;3(12):1212-1217. doi: 10.1001/jamacardio.2018.3798.
PubMed 30476957Capoulade R, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Autoantibodies and immune complexes to oxidation-specific epitopes and progression of aortic stenosis: Results from the ASTRONOMER trial. Atherosclerosis. 2017 May;260:1-7. doi: 10.1016/j.atherosclerosis.2017.03.013. Epub 2017 Mar 9.
PubMed 28319871Capoulade R, Chan KL, Yeang C, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Mahmut A, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Oxidized Phospholipids, Lipoprotein(a), and Progression of Calcific Aortic Valve Stenosis. J Am Coll Cardiol. 2015 Sep 15;66(11):1236-1246. doi: 10.1016/j.jacc.2015.07.020.
PubMed 26361154Page A, Dumesnil JG, Clavel MA, Chan KL, Teo KK, Tam JW, Mathieu P, Despres JP, Pibarot P; ASTRONOMER Investigators. Metabolic syndrome is associated with more pronounced impairment of left ventricle geometry and function in patients with calcific aortic stenosis: a substudy of the ASTRONOMER (Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin). J Am Coll Cardiol. 2010 Apr 27;55(17):1867-74. doi: 10.1016/j.jacc.2009.11.083.
PubMed 20413039
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.
- ClinicalTrials.gov ID
- NCT00800800
- Acronym / sponsor ID
- ASTRONOMER / DC-452-0003
- Conditions
- Aortic Stenosis
- Keywords
- progression of aortic stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- Nov 2002
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Dec 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RosuvastatinRosuvastatin 40 mg |
| 2 | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Rosuvastatin40 mg, oral, single dose | Drug | 1 |
| Placebooral, single dose | Drug | 2 |
Primary outcome
The changes in transvalvular aortic velocities and the changes in aortic valve area.
Time frame: Between baseline and close-out measurments.
2 secondary outcomes
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Time frame: Baseline and minimum of 3 year follow-up.
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Time frame: Between baseline and close-out measurments.
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 3 Dec 2010.
- Derived from this study: PubMed 32054669Capoulade R, Torzewski M, Mayr M, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam J, Teo KK, Burnap SA, Schmid J, Gobel N, Franke UFW, Sanchez A, Witztum JL, Yang X, Yeang C, Arsenault B, Despres JP, Pibarot P, Tsimikas S. ApoCIII-Lp(a) complexes in conjunction with Lp(a)-OxPL predict rapid progression of aortic stenosis. Heart. 2020 May;106(10):738-745. doi: 10.1136/heartjnl-2019-315840. Epub 2020 Feb 13.
- Derived from this study: PubMed 30476957Capoulade R, Yeang C, Chan KL, Pibarot P, Tsimikas S. Association of Mild to Moderate Aortic Valve Stenosis Progression With Higher Lipoprotein(a) and Oxidized Phospholipid Levels: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2018 Dec 1;3(12):1212-1217. doi: 10.1001/jamacardio.2018.3798.
- Derived from this study: PubMed 28319871Capoulade R, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Autoantibodies and immune complexes to oxidation-specific epitopes and progression of aortic stenosis: Results from the ASTRONOMER trial. Atherosclerosis. 2017 May;260:1-7. doi: 10.1016/j.atherosclerosis.2017.03.013. Epub 2017 Mar 9.
- Derived from this study: PubMed 26361154Capoulade R, Chan KL, Yeang C, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Mahmut A, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Oxidized Phospholipids, Lipoprotein(a), and Progression of Calcific Aortic Valve Stenosis. J Am Coll Cardiol. 2015 Sep 15;66(11):1236-1246. doi: 10.1016/j.jacc.2015.07.020.
- Derived from this study: PubMed 20413039Page A, Dumesnil JG, Clavel MA, Chan KL, Teo KK, Tam JW, Mathieu P, Despres JP, Pibarot P; ASTRONOMER Investigators. Metabolic syndrome is associated with more pronounced impairment of left ventricle geometry and function in patients with calcific aortic stenosis: a substudy of the ASTRONOMER (Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin). J Am Coll Cardiol. 2010 Apr 27;55(17):1867-74. doi: 10.1016/j.jacc.2009.11.083.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites 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 Aortic Stenosis, run by AstraZeneca at 15 sites 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 4 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 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The changes in transvalvular aortic velocities and the changes in aortic valve area. (time frame: Between baseline and close-out measurments.). 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 NCT00800800, which also lists 5 linked publications.
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 3 Dec 2010.