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Effects of Rosuvastatin on Aortic Stenosis Progression (ASTRONOMER)

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring progression of aortic stenosis

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Rosuvastatin 40 mg

placebo

Outcomes

Primary Outcome Measures

The changes in transvalvular aortic velocities and the changes in aortic valve area.

Secondary Outcome Measures

The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.

Full Information

First Posted
November 25, 2008
Last Updated
December 2, 2010
Sponsor
AstraZeneca
Collaborators
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00800800
Brief Title
Effects of Rosuvastatin on Aortic Stenosis Progression
Acronym
ASTRONOMER
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
progression of aortic stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Rosuvastatin 40 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
40 mg, oral, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, single dose
Primary Outcome Measure Information:
Title
The changes in transvalvular aortic velocities and the changes in aortic valve area.
Time Frame
Between baseline and close-out measurments.
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research site
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Research site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research site
City
Edmonton
State/Province
Manitoba
Country
Canada
Facility Name
Research site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Cambridge
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Montreal
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research site
City
Halifax
Country
Canada
Facility Name
Research site
City
St. John's
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32054669
Citation
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.
Results Reference
derived
PubMed Identifier
30476957
Citation
Capoulade 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.
Results Reference
derived
PubMed Identifier
28319871
Citation
Capoulade 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.
Results Reference
derived
PubMed Identifier
26361154
Citation
Capoulade 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.
Results Reference
derived
PubMed Identifier
20413039
Citation
Page 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.
Results Reference
derived

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Effects of Rosuvastatin on Aortic Stenosis Progression

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