NCT00214630

Brief Summary

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Trial Health

93
On Track

Trial Health Score

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

Enrollment
825

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2003

Typical duration for phase_3

Geographic Reach
5 countries

56 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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

3.7 years

First QC Date

September 21, 2005

Last Update Submit

November 18, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Also known as: Crestor
Also known as: Lipitor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy

You may not qualify if:

  • Previous Q-wave infarct within the last 4 weeks
  • CK elevation not caused by myocardial injury
  • uncontrolled hypertension at time of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

Research Site

San Diego, California, United States

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Torrance, California, United States

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Bridgeport, Connecticut, United States

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Atlantis, Florida, United States

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Brandon, Florida, United States

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Jacksonville, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Tampa, Florida, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Lombard, Illinois, United States

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Melrose Park, Illinois, United States

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Peoria, Illinois, United States

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Anderson, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Covington, Louisiana, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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Towson, Maryland, United States

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Ann Arbor, Michigan, United States

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Pontiac, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Cincinnati, Ohio, United States

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Fairview Park, Ohio, United States

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Springfield, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Danville, Pennsylvania, United States

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Memphis, Tennessee, United States

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Amarillo, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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Chesapeake, Virginia, United States

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Burien, Washington, United States

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Wausau, Wisconsin, United States

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San José, Costa Rica

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San Salvador, El Salvador

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Ayer, Morocco

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Panama City, Panama

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Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • AstraZeneca Crestor Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 22, 2005

Study Start

December 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations