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Completed

NCT Number: NCT00620542

CRESTOR Athero Imaging Head to Head IVUS Study

A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

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Key information

Conditions

Coronary Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical indication for coronary angiography
  • Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation
  • Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation
  • LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

Exclusion criteria

  • Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
  • Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
  • Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study

Treatment and study plan

Rosuvastatin

Drug

capsule, oral, once daily

Other names: Crestor

atorvastatin

Drug

capsule, oral, one daily

Other names: Lipitor

Primary outcomes

  1. Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)

    Time frame: End of study (Week 104)

    Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:

    [sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.

Secondary outcomes

  1. Numbers of Patients Showing Regression in PAV

    Time frame: End of study (Week 104)

    Regression defined as a change from baseline in PAV < 0

  2. Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)

    Time frame: End of study (Week 104)

    Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.

  3. Numbers of Patients Showing Regression in TAV

    Time frame: End of study (Week 104)

    Regression defined as a change from baseline in TAV < 0

  4. Total Cholesterol Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  5. LDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  6. HDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  7. Triglycerides Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  8. Non-HDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  9. LDL-C/HDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  10. Total Cholesterol/HDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  11. Non-HDL-C/HDL-C Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  12. Apolipoprotein B Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  13. Apolipoprotein A-1 Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  14. Apoliprotein B/Apolipoprotein A-1 Blood Level

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

  15. VLDL-C During the 104 Week Treatment Period

    Time frame: 104 weeks

    Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

Acronym: SATURN

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 21, 2008
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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