Phase 3
N=2,333
CRESTOR Athero Imaging Head to Head IVUS Study
Coronary Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00620542 ↗Enrolled (actual)
2,333
Serious AEs
13.8%
Results posted
Jun 2012
Primary outcome: Primary: Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) — -1.22; -0.99 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rosuvastatin (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) |
-1.22; -0.99 | — |
| SECONDARY Numbers of Patients Showing Regression in PAV |
356; 328 | — |
| SECONDARY Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) |
-6.39; -4.42 | — |
| SECONDARY Numbers of Patients Showing Regression in TAV |
371; 336 | — |
| SECONDARY Total Cholesterol Blood Level |
139.38; 144.05 | — |
| SECONDARY LDL-C Blood Level |
62.64; 70.18 | — |
| SECONDARY HDL-C Blood Level |
50.43; 48.64 | — |
| SECONDARY Triglycerides Blood Level |
132.50; 126.58 | — |
| SECONDARY Non-HDL-C Blood Level |
88.95; 95.41 | — |
| SECONDARY LDL-C/HDL-C Blood Level |
1.30; 1.50 | — |
| SECONDARY Total Cholesterol/HDL-C Blood Level |
2.88; 3.08 | — |
| SECONDARY Non-HDL-C/HDL-C Blood Level |
1.88; 2.08 | — |
| SECONDARY Apolipoprotein B Blood Level |
72.55; 75.12 | — |
| SECONDARY Apolipoprotein A-1 Blood Level |
146.81; 137.68 | — |
| SECONDARY Apoliprotein B/Apolipoprotein A-1 Blood Level |
0.51; 0.56 | — |
| SECONDARY VLDL-C During the 104 Week Treatment Period |
26.05; 25.03 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00620542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.