Trial · NCT00620542
CRESTOR Athero Imaging Head to Head IVUS Study
NCT00620542, Phase 3, Completed, AstraZeneca; results first posted 2012-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CRESTOR Athero Imaging Head to Head IVUS Study. Trials, record NCT00620542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620542
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CRESTOR Athero Imaging Head to Head IVUS Study
- NCT number
- NCT00620542
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,333 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Coronary Atherosclerosis
- Interventions
- Rosuvastatin, Atorvastatin
- First posted
- 2008-02-21
- Last updated
- 2012-07-16
- Results first posted
- 2012-06-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Numbers of Patients Showing Regression in PAV | End of study (Week 104) | Regression defined as a change from baseline in PAV \< 0 |
| Secondary | 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. |
| Secondary | Numbers of Patients Showing Regression in TAV | End of study (Week 104) | Regression defined as a change from baseline in TAV \< 0 |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) | End of study (Week 104) | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | Percent change | MEDIAN |
| SECONDARY | Numbers of Patients Showing Regression in PAV | End of study (Week 104) | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | Participants | NUMBER |
| SECONDARY | Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) | End of study (Week 104) | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mm^3 | MEDIAN |
| SECONDARY | Numbers of Patients Showing Regression in TAV | End of study (Week 104) | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | Participants | NUMBER |
| SECONDARY | Total Cholesterol Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | LDL-C Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | HDL-C Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Triglycerides Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Non-HDL-C Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | LDL-C/HDL-C Blood Level | 104 weeks | Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS). | Ratio | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) | Rosuvastatin 40 mg | -1.22 | 95% Confidence Interval -1.52 to -0.90 | Percent change | |
| Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) | Atorvastatin 80 mg | -0.99 | 95% Confidence Interval -1.19 to -0.63 | Percent change | |
| Numbers of Patients Showing Regression in PAV | Rosuvastatin 40 mg | 356 | Participants | ||
| Numbers of Patients Showing Regression in PAV | Atorvastatin 80 mg | 328 | Participants | ||
| Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) | Rosuvastatin 40 mg | -6.39 | 95% Confidence Interval -7.52 to -5.12 | mm^3 | |
| Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) | Atorvastatin 80 mg | -4.42 | 95% Confidence Interval -5.98 to -3.26 | mm^3 | |
| Numbers of Patients Showing Regression in TAV | Rosuvastatin 40 mg | 371 | Participants | ||
| Numbers of Patients Showing Regression in TAV | Atorvastatin 80 mg | 336 | Participants | ||
| Total Cholesterol Blood Level | Rosuvastatin 40 mg | 139.38 | Standard Error 1.24 | mg/dL | |
| Total Cholesterol Blood Level | Atorvastatin 80 mg | 144.05 | Standard Error 1.23 | mg/dL |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Run-in - 2 Weeks) | STARTED | Rosuvastatin 20 mg | 1,167 | |
| Part A (Run-in - 2 Weeks) | STARTED | Atorvastatin 40 mg | 1,166 | |
| Part A (Run-in - 2 Weeks) | STARTED | Rosuvastatin 40 mg | 0 | |
| Part A (Run-in - 2 Weeks) | STARTED | Atorvastatin 80 mg | 0 | |
| Part A (Run-in - 2 Weeks) | Received Treatment | Rosuvastatin 20 mg | 783 | |
| Part A (Run-in - 2 Weeks) | Received Treatment | Atorvastatin 40 mg | 795 | |
| Part A (Run-in - 2 Weeks) | Received Treatment | Rosuvastatin 40 mg | 0 | |
| Part A (Run-in - 2 Weeks) | Received Treatment | Atorvastatin 80 mg | 0 | |
| Part A (Run-in - 2 Weeks) | COMPLETED | Rosuvastatin 20 mg | 695 | |
| Part A (Run-in - 2 Weeks) | COMPLETED | Atorvastatin 40 mg | 690 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events916
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANGINA PECTORIS | Cardiac disorders | Rosuvastatin 20 mg | 0 | 783 | |
| other | ANGINA PECTORIS | Cardiac disorders | Atorvastatin 40 mg | 0 | 795 | |
| other | ANGINA PECTORIS | Cardiac disorders | Rosuvastatin 40 mg | 61 | 691 | |
| other | ANGINA PECTORIS | Cardiac disorders | Atorvastatin 80 mg | 65 | 689 | |
| other | FATIGUE | General disorders | Rosuvastatin 20 mg | 0 | 783 | |
| other | FATIGUE | General disorders | Atorvastatin 40 mg | 0 | 795 | |
| other | FATIGUE | General disorders | Rosuvastatin 40 mg | 32 | 691 | |
| other | FATIGUE | General disorders | Atorvastatin 80 mg | 39 | 689 | |
| other | MYALGIA | Musculoskeletal and connective tissue disorders | Rosuvastatin 20 mg | 0 | 783 | |
| other | MYALGIA | Musculoskeletal and connective tissue disorders | Atorvastatin 40 mg | 0 | 795 |
1 to 10 of 916Source ClinicalTrials.gov
See all 916 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin 20 mg | ||
| Total, all-cause mortality | Atorvastatin 40 mg | ||
| Total, all-cause mortality | Rosuvastatin 40 mg | ||
| Total, all-cause mortality | Atorvastatin 80 mg | ||
| Total, other adverse events | Rosuvastatin 20 mg | 0 | 783 |
| Total, other adverse events | Atorvastatin 40 mg | 0 | 795 |
| Total, other adverse events | Rosuvastatin 40 mg | 210 | 691 |
| Total, other adverse events | Atorvastatin 80 mg | 213 | 689 |
| Total, serious adverse events | Rosuvastatin 20 mg | 21 | 783 |
| Total, serious adverse events | Atorvastatin 40 mg | 25 | 795 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rosuvastatin 40 mg vs Atorvastatin 80 mg: Numbers of Patients Showing Regression in TAV | Trial comparisons |
| Rosuvastatin 40 mg vs Atorvastatin 80 mg: Numbers of Patients Showing Regression in PAV | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00620542
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