CRESTOR Athero Imaging Head to Head IVUS Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Atherosclerosis	Drug: Rosuvastatin Drug: Atorvastatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease

Drug Information available for: Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	2333
Study Start Date:	January 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rosuvastatin 20 mg Rosuvastatin 20 mg distributed in 2-week run-in period	Drug: Rosuvastatin capsule, oral, once daily Other Name: Crestor
Active Comparator: Atorvastatin 40 mg Atorvastatin 40 mg distributed in 2-week run-in period	Drug: Atorvastatin capsule, oral, one daily Other Name: Lipitor
Experimental: Rosuvastatin 40 mg Rosuvastatin 40 mg distributed in core 2-year study	Drug: Rosuvastatin capsule, oral, once daily Other Name: Crestor
Active Comparator: Atorvastatin 80 mg Atorvastatin 80 mg distributed in core 2-year study	Drug: Atorvastatin capsule, oral, one daily Other Name: Lipitor

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620542

Show 195 Study Locations

Sponsors and Collaborators

AstraZeneca

The Cleveland Clinic

Investigators

Principal Investigator:

Stephen J Nicholls, MBBS, PhD

Cleveland Clinic Foundation, Cardiovascular Medicine

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00620542 History of Changes
Other Study ID Numbers:	D356IC00001, 2007-004000-13
Study First Received:	February 6, 2008
Results First Received:	May 22, 2012
Last Updated:	July 11, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Belgium: Ministry of Social Affairs, Public Health and the Environment Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ministry of Health Mexico: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Coronary artery disease

Additional relevant MeSH terms:

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

Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)