CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00620542
First received: February 6, 2008
Last updated: July 11, 2012
Last verified: July 2012

February 6, 2008
July 11, 2012
January 2008
June 2011   (final data collection date for primary outcome measure)
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) [ Time Frame: End of study (Week 104) ] [ Designated as safety issue: No ]

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.

To compare the effects of rosuvastatin with atorvastatin on the percent atheroma volume (PAV), as measured by IVUS [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00620542 on ClinicalTrials.gov Archive Site
  • Numbers of Patients Showing Regression in PAV [ Time Frame: End of study (Week 104) ] [ Designated as safety issue: No ]
    Regression defined as a change from baseline in PAV < 0
  • Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) [ Time Frame: End of study (Week 104) ] [ Designated as safety issue: No ]
    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.
  • Numbers of Patients Showing Regression in TAV [ Time Frame: End of study (Week 104) ] [ Designated as safety issue: No ]
    Regression defined as a change from baseline in TAV < 0
  • Total Cholesterol Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • LDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • HDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Triglycerides Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Non-HDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • LDL-C/HDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Total Cholesterol/HDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Non-HDL-C/HDL-C Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Apolipoprotein B Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Apolipoprotein A-1 Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • Apoliprotein B/Apolipoprotein A-1 Blood Level [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
  • VLDL-C During the 104 Week Treatment Period [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    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.
Regression of percent atheroma volume (PAV) , as measured by IVUS [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CRESTOR Athero Imaging Head to Head IVUS Study
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Atherosclerosis
  • Drug: Rosuvastatin
    capsule, oral, once daily
    Other Name: Crestor
  • Drug: Atorvastatin
    capsule, oral, one daily
    Other Name: Lipitor
  • Experimental: Rosuvastatin 20 mg
    Rosuvastatin 20 mg distributed in 2-week run-in period
    Intervention: Drug: Rosuvastatin
  • Active Comparator: Atorvastatin 40 mg
    Atorvastatin 40 mg distributed in 2-week run-in period
    Intervention: Drug: Atorvastatin
  • Experimental: Rosuvastatin 40 mg
    Rosuvastatin 40 mg distributed in core 2-year study
    Intervention: Drug: Rosuvastatin
  • Active Comparator: Atorvastatin 80 mg
    Atorvastatin 80 mg distributed in core 2-year study
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2333
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Hungary,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain
 
NCT00620542
D356IC00001, 2007-004000-13
Not Provided
AstraZeneca
AstraZeneca
The Cleveland Clinic
Principal Investigator: Stephen J Nicholls, MBBS, PhD Cleveland Clinic Foundation, Cardiovascular Medicine
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP