CRESTOR Athero Imaging Head to Head IVUS Study

Phase 3

Completed

Conditions: Coronary Atherosclerosis

Interventions: Drug: Atorvastatin
Drug: Rosuvastatin

Registration Number: NCT00620542

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2333

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 40 mg	Atorvastatin	Atorvastatin 40 mg distributed in 2-week run-in period
Rosuvastatin 20 mg	Rosuvastatin	Rosuvastatin 20 mg distributed in 2-week run-in period
Rosuvastatin 40 mg	Rosuvastatin	Rosuvastatin 40 mg distributed in core 2-year study
Atorvastatin 80 mg	Atorvastatin	Atorvastatin 80 mg distributed in core 2-year study

Primary Outcome Measures

Name	Time	Method
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)	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 Outcome Measures

Name	Time	Method
Numbers of Patients Showing Regression in PAV	End of study (Week 104)	Regression defined as a change from baseline in PAV \< 0
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)	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.
Numbers of Patients Showing Regression in TAV	End of study (Week 104)	Regression defined as a change from baseline in TAV \< 0
Total Cholesterol Blood Level	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.
LDL-C Blood Level	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.
HDL-C Blood Level	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.
Triglycerides Blood Level	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.
Non-HDL-C Blood Level	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.
LDL-C/HDL-C Blood Level	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.
Total Cholesterol/HDL-C Blood Level	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.
Non-HDL-C/HDL-C Blood Level	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.
Apolipoprotein B Blood Level	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.
Apolipoprotein A-1 Blood Level	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.
Apoliprotein B/Apolipoprotein A-1 Blood Level	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.
VLDL-C During the 104 Week Treatment Period	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.