Back to resultsLUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
Primary Purpose
Acute Coronary Syndromes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rosuvastatin calcium
atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndromes
Eligibility Criteria
Inclusion Criteria: Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy Exclusion Criteria: Previous Q-wave infarct within the last 4 weeks CK elevation not caused by myocardial injury uncontrolled hypertension at time of randomization
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Outcomes
Primary Outcome Measures
Reduction of LDL-C following 12 weeks of treatment
Secondary Outcome Measures
% 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00214630
Brief Title
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
825 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rosuvastatin calcium
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Primary Outcome Measure Information:
Title
Reduction of LDL-C following 12 weeks of treatment
Secondary Outcome Measure Information:
Title
% 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy
Exclusion Criteria:
Previous Q-wave infarct within the last 4 weeks
CK elevation not caused by myocardial injury
uncontrolled hypertension at time of randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Crestor Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
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Research Site
City
Bridgeport
State/Province
Connecticut
Country
United States
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Research Site
City
Atlantis
State/Province
Florida
Country
United States
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Research Site
City
Brandon
State/Province
Florida
Country
United States
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Research Site
City
Jacksonville
State/Province
Florida
Country
United States
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City
Pensacola
State/Province
Florida
Country
United States
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City
Safety Harbor
State/Province
Florida
Country
United States
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Research Site
City
Tampa
State/Province
Florida
Country
United States
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City
Aurora
State/Province
Illinois
Country
United States
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City
Chicago
State/Province
Illinois
Country
United States
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City
Lombard
State/Province
Illinois
Country
United States
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Research Site
City
Melrose Park
State/Province
Illinois
Country
United States
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Research Site
City
Peoria
State/Province
Illinois
Country
United States
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City
Anderson
State/Province
Indiana
Country
United States
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City
Indianapolis
State/Province
Indiana
Country
United States
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Des Moines
State/Province
Iowa
Country
United States
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Louisville
State/Province
Kentucky
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United States
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Owensboro
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Kentucky
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United States
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Covington
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Louisiana
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United States
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Shreveport
State/Province
Louisiana
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United States
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Annapolis
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Maryland
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United States
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Towson
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Maryland
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United States
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Ann Arbor
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Michigan
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United States
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Pontiac
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Michigan
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United States
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Troy
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Michigan
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United States
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Minneapolis
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Minnesota
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United States
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St. Paul
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Minnesota
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United States
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Tupelo
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Mississippi
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United States
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Kansas City
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Missouri
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United States
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St. Louis
State/Province
Missouri
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United States
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Kalispell
State/Province
Montana
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United States
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Newark
State/Province
New Jersey
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United States
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Albuquerque
State/Province
New Mexico
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United States
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Rochester
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New York
Country
United States
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Asheville
State/Province
North Carolina
Country
United States
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Cincinnati
State/Province
Ohio
Country
United States
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Fairview Park
State/Province
Ohio
Country
United States
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City
Springfield
State/Province
Ohio
Country
United States
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Oklahoma City
State/Province
Oklahoma
Country
United States
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City
Tulsa
State/Province
Oklahoma
Country
United States
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City
Bend
State/Province
Oregon
Country
United States
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City
Portland
State/Province
Oregon
Country
United States
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City
Danville
State/Province
Pennsylvania
Country
United States
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Memphis
State/Province
Tennessee
Country
United States
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Amarillo
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Texas
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United States
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Beaumont
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Texas
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United States
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Dallas
State/Province
Texas
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United States
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Lubbock
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Texas
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United States
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Chesapeake
State/Province
Virginia
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United States
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Burien
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Washington
Country
United States
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Wausau
State/Province
Wisconsin
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United States
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San Jose
Country
Costa Rica
Facility Name
Research Site
City
San Salvador
Country
El Salvador
Facility Name
Research Site
City
Ayer
Country
Morocco
Facility Name
Research Site
City
Panama City
Country
Panama
12. IPD Sharing Statement
Citations:
PubMed Identifier
18402897
Citation
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.
Results Reference
derived
Learn more about this trial
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
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