NCT00800800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

5.8 years

First QC Date

November 25, 2008

Last Update Submit

December 2, 2010

Conditions

Aortic Stenosis

Keywords

progression of aortic stenosis

Outcome Measures

Primary Outcomes (1)

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

    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.

    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.

    Between baseline and close-out measurments.

Study Arms (2)

1

ACTIVE COMPARATOR

Rosuvastatin 40 mg

Drug: Rosuvastatin

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

RosuvastatinDRUG

40 mg, oral, single dose

1
PlaceboDRUG

oral, single dose

2

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research site

Calgary, Alberta, Canada

Location

Research site

Edmonton, Alberta, Canada

Location

Research site

Surrey, British Columbia, Canada

Location

Research site

Vancouver, British Columbia, Canada

Location

Research site

Victoria, British Columbia, Canada

Location

Research site

Edmonton, Manitoba, Canada

Location

Research site

Brampton, Ontario, Canada

Location

Research site

Cambridge, Ontario, Canada

Location

Research site

Kitchener, Ontario, Canada

Location

Research site

Montreal, Ontario, Canada

Location

Research site

Ottawa, Ontario, Canada

Location

Research site

Toronto, Ontario, Canada

Location

Research site

Montreal, Quebec, Canada

Location

Research site

Halifax, Canada

Location

Research site

St. John's, Canada

Location

Related Publications (5)

  • 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.

    PMID: 32054669DERIVED

  • 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.

    PMID: 30476957DERIVED

  • 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.

    PMID: 28319871DERIVED

  • 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.

    PMID: 26361154DERIVED

  • 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.

    PMID: 20413039DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2008

First Posted

December 2, 2008

Study Start

November 1, 2002

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

CA(15)