Acute Coronary SyndromesPhase 3NCT00214630
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
A Phase 3 study testing rosuvastatin calcium and atorvastatin in people with Acute Coronary Syndromes, run by AstraZeneca at 56 sites in 5 countries.
Trial summary
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- rosuvastatin calcium and atorvastatin
- How many people
- 825 participants
- Where
- 56 sitesin 5 countries
- Study dates
- Dec 2003to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy
Who cannot join
- Previous Q-wave infarct within the last 4 weeks
- CK elevation not caused by myocardial injury
- uncontrolled hypertension at time of randomization
Trial locations and contacts
56 sites in 5 countries.
56 sites in 5 countries
United States52 sites
Research Site
Albuquerque, New Mexico
Research Site
Amarillo, Texas
Research Site
Anderson, Indiana
Research Site
Ann Arbor, Michigan
Research Site
Annapolis, Maryland
Research Site
Asheville, North Carolina
Research Site
Atlantis, Florida
Research Site
Aurora, Illinois
Research Site
Beaumont, Texas
Research Site
Bend, Oregon
Research Site
Brandon, Florida
Research Site
Bridgeport, Connecticut
Research Site
Burien, Washington
Research Site
Chesapeake, Virginia
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Covington, Louisiana
Research Site
Dallas, Texas
Research Site
Danville, Pennsylvania
Research Site
Des Moines, Iowa
Research Site
Fairview Park, Ohio
Research Site
Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
Kalispell, Montana
Research Site
Kansas City, Missouri
Research Site
Lombard, Illinois
Research Site
Louisville, Kentucky
Research Site
Lubbock, Texas
Research Site
Melrose Park, Illinois
Research Site
Memphis, Tennessee
Research Site
Minneapolis, Minnesota
Research Site
Newark, New Jersey
Research Site
Oklahoma City, Oklahoma
Research Site
Owensboro, Kentucky
Research Site
Pensacola, Florida
Research Site
Peoria, Illinois
Research Site
Pontiac, Michigan
Research Site
Portland, Oregon
Research Site
Rochester, New York
Research Site
Safety Harbor, Florida
Research Site
Saint Paul, Minnesota
Research Site
San Diego, California
Research Site
Shreveport, Louisiana
Research Site
Springfield, Ohio
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
Torrance, California
Research Site
Towson, Maryland
Research Site
Troy, Michigan
Research Site
Tulsa, Oklahoma
Research Site
Tupelo, Mississippi
Research Site
Wausau, Wisconsin
About this study
Official title: A 12-week Randomized, Open-label 3-arm, Parallel Group, Multicenter Phase IIIb Study Comparing Efficacy and Safety of Rosuvastatin 20mg and 40mg With That of Atorvastatin 80 mg in Subjects With Acute Coronary Syndromes
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes
- Conditions
- Acute Coronary Syndromes
- Being tested
- rosuvastatin calcium, 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.
rosuvastatin calciumDrug
Also called Crestor
atorvastatinDrug
Also called Lipitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of LDL-C following 12 weeks of treatment
Secondary outcomes (1)
% change from baseline in LDL-C following 2 & 6 weeks of treatment; % change from baseline in TC, HDL-C, triglycerides, non-HDL-C, apolipoprotein A-1, apolipoprotein B, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB/Apo A-1 @ weeks 6 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionAug 2007
- Study completionAug 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 SyndromesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Crestor Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214630
- Sponsor's protocol ID
- 4522US/0001
- Other IDs
- D3560L00021, LUNAR
- Status last verified
- Nov 2010
- First submitted
- 21 Sep 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Publications
Pitt B, Loscalzo J, Ycas J, Raichlen JS. Lipid levels after acute coronary syndromes. J Am Coll Cardiol. 2008 Apr 15;51(15):1440-5. doi: 10.1016/j.jacc.2007.11.075.
PubMed 18402897
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Open-label 3-arm, Parallel Group, Multicenter Phase IIIb Study Comparing Efficacy and Safety of Rosuvastatin 20mg and 40mg With That of Atorvastatin 80 mg in Subjects With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00214630
- Acronym / sponsor ID
- 4522US/0001
- Conditions
- Acute Coronary Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Sep 2005 (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.
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy
Key exclusion criteria (3 listed)
- Previous Q-wave infarct within the last 4 weeks
- CK elevation not caused by myocardial injury
- uncontrolled hypertension at time of randomization
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 calciumAlso: Crestor | Drug | – |
| atorvastatinAlso: Lipitor | Drug | – |
Primary outcome
Reduction of LDL-C following 12 weeks of treatment
1 secondary outcome
% change from baseline in LDL-C following 2 & 6 weeks of treatment; % change from baseline in TC, HDL-C, triglycerides, non-HDL-C, apolipoprotein A-1, apolipoprotein B, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB/Apo A-1 @ weeks 6 & 12
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 19 Nov 2010.
- Derived from this study: PubMed 18402897Pitt B, Loscalzo J, Ycas J, Raichlen JS. Lipid levels after acute coronary syndromes. J Am Coll Cardiol. 2008 Apr 15;51(15):1440-5. doi: 10.1016/j.jacc.2007.11.075.
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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 Crestor Medical Science Director, MD study director
AstraZeneca
56 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rosuvastatin calcium and atorvastatin in people with Acute Coronary Syndromes, run by AstraZeneca at 56 sites in 5 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 1 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 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Costa Rica, El Salvador, Morocco, Panama. 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?
Reduction of LDL-C following 12 weeks of treatment. 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 NCT00214630, 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 19 Nov 2010.