Condition category
Circulatory System
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kwan-Leung Chan

ORCID ID

Contact details

Dr. K. L. Chan & Adult Congenital Heart Clinic
Room 3411
University of Ottawa Heart Institute
40 Ruskin Street
Ottawa
K1Y 4W7
Canada
+1 613 761 4189
kchan@ottawaheart.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DCT-42878

Study information

Scientific title

Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis: a randomised controlled trial

Acronym

ASTRONOMER

Study hypothesis

Primary hypothesis is that patients taking a statin will experience a smaller increase in aortic transvalvular gradients and a smaller decrease in aortic valve area than patients taking placebo over a three-year follow-up period.

Secondary hypotheses are that:
1. The event rate (cardiac death and aortic valve replacement) at the end of three years will be lower
2. The time to outcome events is longer in patients taking a statin than in patients taking placebo

Ethics approval

University of Ottawa Heart Institute Ethics Committee gave approval on the 3rd October 2002.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Aortic stenosis (AS)

Intervention

Rosuvastatin 40 mg daily versus placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Rosuvastatin

Primary outcome measures

Changes in peak transvalvular aortic velocity, transvalvular gradients and aortic valve area

Secondary outcome measures

1. Cardiac death measured at the end of three years of follow-up
2. Aortic valve replacement

Overall trial start date

01/12/2002

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 to 82 years
2. Both men and women will be included
3. At least mild AS defined by peak Doppler aortic valve velocity = 2.5 m/sec
4. Moderate risk for coronary artery disease (CAD), with low density lipoprotein cholesterol (LDL-C) less than 4 mmol/l and total cholesterol: high density lipoprotein cholesterol (HDL-C) ratio less than 6
5. Low risk for CAD with LDL-C less than 5 mmol/l and total cholesterol: HDL-C less than 7

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

264

Participant exclusion criteria

1. Peak Doppler aortic valve velocity less than 2.5 m/sec, because of the rate of progression in these patients is not well defined
2. Severe AS (a mean aortic gradient = 40 mmHg or AVA = 0.9 cm^2). These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
3. Symptomatic AS
4. Greater than moderate aortic regurgitation
5. Patients with significant concomitant mitral valve disease, defined by greater than moderate MR or MVA less than 2.0 cm^2
6. Patients on cholesterol lowering agents
7. Symptomatic coronary artery disease
8. Diabetes mellitus either on oral agent or insulin
9. At high or very high risks for CAD (10 year risk greater than 20%)
10. Moderate risk for CAD, but LDL-C greater than 4 mmol/l or total cholesterol: HDL-C ratio greater than 6
11. Low risk for CAD, but LDL-C greater than 5 mmol/l or total cholesterol: HDL-C ratio greater than 7
12. Pregnant or lactating women
13. Inability to return for follow up visits
14. Concomitant medical conditions, which limit the survival in the next 5 years
15. Inability or unwillingness to provide informed consent

Recruitment start date

01/12/2002

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Canada

Trial participating centre

Dr. K. L. Chan & Adult Congenital Heart Clinic
Ottawa
K1Y 4W7
Canada

Sponsor information

Organisation

University of Ottawa (Canada)

Sponsor details

451 Smyth Road
P.O. Box 450
Station A
Ottawa
K1N 6N5
Canada

Sponsor type

Not defined

Website

http://www.uottawa.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-42878)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 trial design in http://www.ncbi.nlm.nih.gov/pubmed/17540192
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20048204

Publication citations

  1. Results

    Chan KL, Teo K, Dumesnil JG, Ni A, Tam J, , Effect of Lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial., Circulation, 2010, 121, 2, 306-314, doi: 10.1161/CIRCULATIONAHA.109.900027.

  2. Chan KL, Teo K, Tam J, Dumesnil JG, , Rationale, design, and baseline characteristics of a randomized trial to assess the effect of cholesterol lowering on the progression of aortic stenosis: the Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin (ASTRONOMER) trial., Am. Heart J., 2007, 153, 6, 925-931, doi: 10.1016/j.ahj.2007.03.011.

Additional files

Editorial Notes