Clinical trial NCT00214630: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndromes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of rosuvastatin and atorvastatin in subjects with 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

Primary outcomes:
measure: Reduction of LDL-C following 12 weeks of treatment
Secondary outcomes:
measure: % 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
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Safety Harbor
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Aurora
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lombard
country: United States
facility: Research Site
state: Illinois
city: Melrose Park
country: United States
facility: Research Site
state: Illinois
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Anderson
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Covington
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Pontiac
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: Tupelo
country: United States
facility: Research Site
state: Mississippi
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Kalispell
country: United States
facility: Research Site
state: Montana
city: Newark
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Rochester
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Fairview Park
country: United States
facility: Research Site
state: Ohio
city: Springfield
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Bend
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Danville
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Beaumont
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Burien
country: United States
facility: Research Site
state: Washington
city: Wausau
country: United States
facility: Research Site
state: Wisconsin
city: San Jose
country: Costa Rica
facility: Research Site
city: San Salvador
country: El Salvador
facility: Research Site
city: Ayer
country: Morocco
facility: Research Site
city: Panama City
country: Panama
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Science Director, MD
role: STUDY_DIRECTOR
References:
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.