Trial · NCT02546323
A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
NCT02546323, Phase 3, Completed, AstraZeneca; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis. Trials, record NCT02546323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02546323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
- NCT number
- NCT02546323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 543 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Atherosclerosis
- Interventions
- Rosuvastatin, Placebo
- First posted
- 2015-09-10
- Last updated
- 2019-12-11
- Results first posted
- 2019-12-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. |
| Secondary | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. |
| Secondary | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | CIMT measurements were made from ultrasound images of the near and far walls of the right and left carotid bulb. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. |
| Secondary | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | CIMT measurements were made from ultrasound images of the near and far walls of the right and left ICA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. |
| Secondary | Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the mean of the CIMT for this segment. The annualized rate of change in the MeanMean CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. |
| Secondary | Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF) | From baseline (Week 0) to end-of-study (Week 104). | The percent change from baseline at final visit for lipid and lipoprotein measurements (low-density lipoprotein cholesterol \[LDL-C\], total cholesterol, high-density lipoprotein cholesterol \[HDL-C\], triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) and apolipoprotein measurements (apolipoprotein A-I \[ApoA-I\], apolipoprotein B \[ApoB\] and ApoB/ApoA-I ratio) was determined by analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0) to the final visit at Week 104, any missing observations were imputed by LOCF. |
| Secondary | Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average | From baseline (Week 0) to end-of-study (Week 104). | The percent change from baseline at final visit for lipid and lipoprotein measurements (LDL-C, total cholesterol, HDL-C, triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) was determined by ANCOVA with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0), the time-weighted average value was calculated as the value multiplied by the number of days since the last assessment, summed for all observations, and divided by the sum of days between all visits. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | mm/year | MEAN |
| SECONDARY | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | mm/year | MEAN |
| SECONDARY | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | mm/year | MEAN |
| SECONDARY | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | mm/year | MEAN |
| SECONDARY | Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA | From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | mm/year | MEAN |
| SECONDARY | Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF) | From baseline (Week 0) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average | From baseline (Week 0) to end-of-study (Week 104). | The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period | Rosuvastatin 20 mg | 0.0038 | Standard Error 0.00312 | mm/year | |
| Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period | Placebo | 0.0142 | Standard Error 0.00317 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA | Rosuvastatin 20 mg | -0.0031 | Standard Error 0.00310 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA | Placebo | 0.0079 | Standard Error 0.00315 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb | Rosuvastatin 20 mg | 0.0067 | Standard Error 0.00634 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb | Placebo | 0.0228 | Standard Error 0.00643 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA | Rosuvastatin 20 mg | 0.0077 | Standard Error 0.00502 | mm/year | |
| Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA | Placebo | 0.0120 | Standard Error 0.00511 | mm/year | |
| Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA | Rosuvastatin 20 mg | -0.0011 | Standard Error 0.00191 | mm/year | |
| Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA | Placebo | 0.0075 | Standard Error 0.00194 | mm/year |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin 20 mg | 272 | |
| Overall Study | STARTED | Placebo | 271 | |
| Overall Study | Received Treatment | Rosuvastatin 20 mg | 272 | |
| Overall Study | Received Treatment | Placebo | 268 | |
| Overall Study | COMPLETED | Rosuvastatin 20 mg | 212 | |
| Overall Study | COMPLETED | Placebo | 205 | |
| Overall Study | NOT COMPLETED | Rosuvastatin 20 mg | 60 | |
| Overall Study | NOT COMPLETED | Placebo | 66 |
Source ClinicalTrials.gov
Adverse events158
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 | Toothache | Gastrointestinal disorders | Rosuvastatin 20 mg | 23 | 272 | 39 |
| other | Toothache | Gastrointestinal disorders | Placebo | 15 | 268 | 23 |
| other | Nasopharyngitis | Infections and infestations | Rosuvastatin 20 mg | 52 | 272 | 79 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 56 | 268 | 77 |
| other | Upper respiratory tract infection | Infections and infestations | Rosuvastatin 20 mg | 49 | 272 | 74 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 54 | 268 | 71 |
| other | Blood glucose increased | Investigations | Rosuvastatin 20 mg | 24 | 272 | 24 |
| other | Blood glucose increased | Investigations | Placebo | 18 | 268 | 18 |
| other | Protein urine present | Investigations | Rosuvastatin 20 mg | 16 | 272 | 16 |
| other | Protein urine present | Investigations | Placebo | 9 | 268 | 10 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin 20 mg | 0 | 272 |
| Total, all-cause mortality | Placebo | 1 | 268 |
| Total, other adverse events | Rosuvastatin 20 mg | 144 | 272 |
| Total, other adverse events | Placebo | 142 | 268 |
| Total, serious adverse events | Rosuvastatin 20 mg | 38 | 272 |
| Total, serious adverse events | Placebo | 34 | 268 |
Source ClinicalTrials.gov
Papers3
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 20 mg vs Placebo: deaths from any cause | Trial comparisons |
| Rosuvastatin 20 mg vs Placebo: serious adverse events | 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.
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