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

Sponsor:	AstraZeneca
Collaborator:	The Cleveland Clinic
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00620542

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 80mg 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 III

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 Ultrasound

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Regression of percent atheroma volume (PAV) , as measured by IVUS [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	1300
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: 1	Drug: Rosuvastatin capsule, oral, once daily Other Name: Crestor
Active Comparator: 2	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 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 199 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:	Michael Cressman, Executive Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00620542 History of Changes
Other Study ID Numbers:	D356IC00001, 2007-004000-13
Study First Received:	February 6, 2008
Last Updated:	July 6, 2011
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 - French Health Products Safety Agency; 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 February 09, 2012