Acute Coronary SyndromePhase 3NCT00296387
Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome
A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Acute Coronary Syndrome, run by AstraZeneca at 102 sites in 11 countries.
Trial summary
The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Rosuvastatin and Atorvastatin
- How many people
- 1,160 participants
- Where
- 102 sitesin 11 countries
- Study dates
- Jan 2006to Oct 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion,
- Percutaneous coronary intervention (PCI) planned,
- Evidence of coronary artery disease
Who cannot join
- Hypersensitivity to statins
- Any cholesterol lowering medication taken within 1 month prior V1
- Sustained ST-segment elevation on ECG
Trial locations and contacts
102 sites in 11 countries.
102 sites in 11 countries
France34 sites
Research Site
Amiens
Research Site
Annecy
Research Site
Arras
Research Site
Avignon
Research Site
Boulogne-Billancourt
Research Site
Caen
Research Site
Cholet
Research Site
Créteil
Research Site
Dijon
Research Site
Eaubonne
Research Site
Évecquemont
Research Site
Falaise
Research Site
La Roche-sur-Yon
Research Site
Lagny-sur-Marne
Research Site
Le Coudray
Research Site
Le Mans
Research Site
Lille
Research Site
Marseille
Research Site
Metz
Research Site
Montpellier
Research Site
Nevers
Research Site
Paris
Research Site
Pau
Research Site
Pessac
Research Site
Reims
Research Site
Rouen
Research Site
Saint-Herblain
Research Site
Suresnes
Research Site
Toulouse
Research Site
Tourcoing
Research Site
Tours
Research Site
Valenciennes
Research Site
Vannes
Research Site
Villeurbanne
Canada17 sites
Research Site
Edmonton, Alberta
Research Site
Halifax, Nova Scotia
Research Site
Kingston, Ontario
Research Site
Laval, Quebec
Research Site
London, Ontario
Research Site
Montreal, Quebec
Research Site
Pointe-Claire, Quebec
Research Site
Regina, Saskatchewan
Research Site
Saint John, New Brunswick
Research Site
Saint-Charles-Borromée, Quebec
Research Site
Scarborough Village, Ontario
Research Site
Sherbrooke, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Research Site
Victoria, British Columbia
Research Site
Winnipeg, Manitoba
Italy13 sites
Research Site
Bari, Apulia
Research Site
Benevento, Campania
Research Site
Bolzano
Research Site
Catania, Sicily
Research site
Cosenza, Basilicate
Research Site
Mantua, Lombardy
Research Site
Naples
Research Site
Padova
Research Site
Perugia, Umbria
Research Site
Pisa, Tuscany
Research Site
Roma
Research Site
Rozzano (Milano), Lombardy
Research Site
Verona, Veneto
Belgium9 sites
Research Site
Aalst
Research Site
Bonheiden
Research Site
Bouge
Research Site
Brussels
Research Site
Charleroi
Research Site
Hasselt
Research Site
Huy
Research Site
La Louvière
Research Site
Leuven
Spain8 sites
Research Site
Fuenlabrada(Madrid), Madrid
Research site
Madrid, Madrid
Research Site
Sant Joan d'Alacant, Valencia
Research Site
Seville
Research Site
Tarragona, Catalonia
Research Site
Toledo, Castille-La Mancha
Research Site
Vigo, Pontevedra
Research Site
Zaragoza, Aragon
Portugal7 sites
Research Site
Aveiro
Research Site
Braga
Research Site
Carnaxide
Research Site
Faro
Research Site
Funchal
Research Site
Leiria
Research Site
Vila Real
Hungary4 sites
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Pécs
Research Site
Zalaegerszeg
Tunisia4 sites
Research Site
BAB Saâdoun Tunis
Research Site
SIDI Daoud Tunis
Research Site
Sousse
Research Site
Tunis
About this study
Official title: Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS
The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Rosuvastatin, Atorvastatin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes in ApoB/ApoA-I levels
Measured: from Day 0 to 3 months
Secondary outcomes (3)
Percentage changes in LDL-C
Measured: from Day 0 to 1 month and 3 months
Percentage changes in the hs-CRP and AUC of hs-CRP levels
Measured: from Day -6 to Day 0
Percentage changes in ApoA-I
Measured: from Day 0 to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startJan 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Double blind
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296387
- Sponsor's protocol ID
- D3560L00052
- Other IDs
- CENTAURUS
- Status last verified
- Dec 2007
- First submitted
- 23 Feb 2006
- Last updated
- 17 Dec 2007
- Results posted
- No
Publications
Lablanche JM, Leone A, Merkely B, Morais J, Alonso J, Santini M, Eha J, Demil N, Licour M, Tardif JC; CENTAURUS investigators. Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis. 2010 Mar;103(3):160-9. doi: 10.1016/j.acvd.2010.01.005. Epub 2010 Apr 8.
PubMed 20417447
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS
- ClinicalTrials.gov ID
- NCT00296387
- Acronym / sponsor ID
- D3560L00052
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Feb 2006 (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 see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion,
- Percutaneous coronary intervention (PCI) planned,
- Evidence of coronary artery disease
Key exclusion criteria (3 listed)
- Hypersensitivity to statins
- Any cholesterol lowering medication taken within 1 month prior V1
- Sustained ST-segment elevation on ECG
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 |
|---|---|---|
| Rosuvastatin | Drug | – |
| Atorvastatin | Drug | – |
Primary outcome
Percentage changes in ApoB/ApoA-I levels
Time frame: from Day 0 to 3 months
3 secondary outcomes
Percentage changes in LDL-C
Time frame: from Day 0 to 1 month and 3 months
Percentage changes in the hs-CRP and AUC of hs-CRP levels
Time frame: from Day -6 to Day 0
Percentage changes in ApoA-I
Time frame: from Day 0 to 1 month
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 17 Dec 2007.
- Derived from this study: PubMed 20417447Lablanche JM, Leone A, Merkely B, Morais J, Alonso J, Santini M, Eha J, Demil N, Licour M, Tardif JC; CENTAURUS investigators. Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis. 2010 Mar;103(3):160-9. doi: 10.1016/j.acvd.2010.01.005. Epub 2010 Apr 8.
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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.
AstraZeneca France Medical Director, MD study director
AstraZeneca
102 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Acute Coronary Syndrome, run by AstraZeneca at 102 sites in 11 countries.
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 3 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 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in France, Canada, Italy, Belgium, Spain and 6 more countries. 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. 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?
Percentage changes in ApoB/ApoA-I levels (time frame: from Day 0 to 3 months). 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 NCT00296387, which also lists 1 linked publication.
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 17 Dec 2007.