AtherosclerosisPhase 3NCT02546323
A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
A Phase 3 study testing Rosuvastatin in people with Atherosclerosis, run by AstraZeneca at 24 sites in China.
Trial summary
The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis. Read more about this study
- Who is it for?
- Ages 45 to 69 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 543 participants
- Where
- 24 sitesChina
- Study dates
- 17 Sep 2015to 29 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study-specific procedures
- Male aged ≥45 and <70 years or female aged ≥55 and <70 years
- Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on antihypertensive treatment) and age as CVD risk factors and subjects without hypertension who have 3 or more other risk factors (including age) must have "Fasting LDL C of ≥120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1mmol/L)"; Subjects without hypertension who have fewer than 3 other risk factors (including age) must have "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and <190 mg/dL (4.9 mmol/L)"
- Triglycerides <500 mg/dL (5.65 mmol/L) at Visit 1
- HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1
- Maximum IMT ≥1.2 mm and <3.5 mm at any location in the carotid ultrasound scans conducted at both Visit 2 and Visit 3
- Willing to follow all study procedures including study visits, fasting blood draws, and compliance with study treatment regimen
Who cannot join
- Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin combination, within 12 months prior to Visit 1
- Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid metabolism (eg, soluble fibers [including >2 teaspoons Metamucil® or psyllium-containing supplement per day] or other dietary fiber supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)
- History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
- Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test
- Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic disease such as angina, MI, transient ischemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, abdominal aortic aneurysm
- History of cancer (other than basal cell carcinoma) in the past 2 years
Show all 19Show fewer
- Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of ≥110 mmHg or a resting systolic blood pressure of ≥180 mmHg recorded at any time during the screening period
- History of diabetes mellitus or current diabetes mellitus
- Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) >1.5 times the upper limit of normal (ULN) at Visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months
- History of heterozygous or homozygous familial hypercholesterolemia or known hyperlipoproteinemia Types I, III, IV, or V (familial dysbetalipoproteinemia)
- Use of the disallowed concomitant medications within 12 months prior to Visit 1
- History of alcohol and/or drug abuse within the past 5 years
- Active liver disease or hepatic dysfunction as defined by elevations of ≥1.5 x ULN at Visit 1 in any of the following liver function tests: ALT, AST or bilirubin
- Serum creatine kinase (CK) >3 x ULN at Visit 1
- Serum creatinine >2.0 mg/dL (177 mmol/L) recorded during the screening period
- Participation in another investigational drug study, and having ingested investigational drug ≤4 weeks before enrollment in the screening period
- Previous randomization in the present study
- History of a significant medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Research Site
Beijing, 100035
Research Site
Beijing, 100050
Research Site
Beijing, 100191
Research Site
Beijing, 100853
Research Site
Bengbu, 233060
Research Site
Changsha, 410011
Research Site
Chongqin, 400042
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510260
Research Site
Guangzhou, 510515
Research Site
Guangzhou, 510630
Research Site
Haerbin, 150001
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Ningbo, 315010
Research Site
Shanghai, 200032
Research Site
Shanghai, 200065
Research Site
Shanghai, 200090
Research Site
Shenyang, 110001
Research Site
Tianjin, 300457
Research Site
Wenzhou, CN-325000
Research Site
Wuhan, 430022
Research Site
Xi'an, 710061
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects
The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter parallel group study assessing the effects of rosuvastatin 20 mg treatment for 104 weeks on the change in intimamedia thickness (IMT) of the common carotid artery (CCA), carotid bulb, and internal carotid artery (ICA) in adult Chinese subjects with subclinical atherosclerosis.
- Conditions
- Atherosclerosis
- Being tested
- Rosuvastatin, Placebo
- Keywords
- Rosuvastatin 20 mg treatment, Carotid Intima-Media Thickness, Chinese subjects, Subclinical atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
20mg tablets, orally once daily for the duration of the 104-week treatment period
PlaceboDrug
Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | 20 mg tablets, Daily oral dose Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Matching placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Secondary outcomes (6)
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA
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.
Measured: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb
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.
Measured: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA
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.
Measured: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA
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.
Measured: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
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.
Measured: From baseline (Week 0) to end-of-study (Week 104).
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
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.
Measured: From baseline (Week 0) to end-of-study (Week 104).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start17 Sep 2015
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, M.D., Principal investigator, Beijing Tian Tan Hospital, Capital Medical UniversityYundai Chen, M.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546323
- Sponsor's protocol ID
- D3565C00003
- Status last verified
- Oct 2019
- First submitted
- 26 Aug 2015
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PubMed 37565307Zheng H, Li H, Wang Y, Li Z, Hu B, Li X, Fu L, Hu H, Nie Z, Zhao B, Wei D, Karlson BW, Bots ML, Meng X, Chen Y, Wang Y; METEOR-China Investigators. Rosuvastatin Slows Progression of Carotid Intima-Media Thickness: The METEOR-China Randomized Controlled Study. Stroke. 2022 Oct;53(10):3004-3013. doi: 10.1161/STROKEAHA.120.031877. Epub 2022 Aug 26.
PubMed 36017704Wang Y, Wang A, Li H, Li Z, Hu B, Li X, Zheng H, Fu L, Hu H, Nie Z, Qin Y, Zhao B, Wei D, Karlson BW, Bots ML, Chen Y, Wang Y. Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis-design, rationale, and methodology of the METEOR-China study. Trials. 2020 Nov 11;21(1):921. doi: 10.1186/s13063-020-04741-0.
PubMed 33176842
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects
- ClinicalTrials.gov ID
- NCT02546323
- Acronym / sponsor ID
- D3565C00003
- Conditions
- Atherosclerosis
- Keywords
- Rosuvastatin 20 mg treatment, Carotid Intima-Media Thickness, Chinese subjects, Subclinical atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.
Detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter parallel group study assessing the effects of rosuvastatin 20 mg treatment for 104 weeks on the change in intimamedia thickness (IMT) of the common carotid artery (CCA), carotid bulb, and internal carotid artery (ICA) in adult Chinese subjects with subclinical atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin20 mg tablets, Daily oral dose |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent prior to any study-specific procedures
- Male aged ≥45 and <70 years or female aged ≥55 and <70 years
- Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on antihypertensive treatment) and age as CVD risk factors and subjects without hypertension who have 3 or more other risk factors (including age) must have "Fasting LDL C of ≥120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1mmol/L)"; Subjects without hypertension who have fewer than 3 other risk factors (including age) must have "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and <190 mg/dL (4.9 mmol/L)"
- Triglycerides <500 mg/dL (5.65 mmol/L) at Visit 1
- HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1
Key exclusion criteria (19 listed)
- Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin combination, within 12 months prior to Visit 1
- Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid metabolism (eg, soluble fibers [including >2 teaspoons Metamucil® or psyllium-containing supplement per day] or other dietary fiber supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)
- History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
- Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test
- Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic disease such as angina, MI, transient ischemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, abdominal aortic aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor20mg tablets, orally once daily for the duration of the 104-week treatment period | Drug | Rosuvastatin |
| PlaceboMatching placebo tablets, orally once daily for the duration of the 104-week treatment period. | Drug | Placebo |
Primary outcome
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
Time frame: 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.
6 secondary outcomes
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA
Time frame: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb
Time frame: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA
Time frame: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA
Time frame: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
Time frame: From baseline (Week 0) to end-of-study (Week 104).
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
Time frame: From baseline (Week 0) to end-of-study (Week 104).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37565307Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
- Derived from this study: PubMed 36017704Zheng H, Li H, Wang Y, Li Z, Hu B, Li X, Fu L, Hu H, Nie Z, Zhao B, Wei D, Karlson BW, Bots ML, Meng X, Chen Y, Wang Y; METEOR-China Investigators. Rosuvastatin Slows Progression of Carotid Intima-Media Thickness: The METEOR-China Randomized Controlled Study. Stroke. 2022 Oct;53(10):3004-3013. doi: 10.1161/STROKEAHA.120.031877. Epub 2022 Aug 26.
- Derived from this study: PubMed 33176842Wang Y, Wang A, Li H, Li Z, Hu B, Li X, Zheng H, Fu L, Hu H, Nie Z, Qin Y, Zhao B, Wei D, Karlson BW, Bots ML, Chen Y, Wang Y. Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis-design, rationale, and methodology of the METEOR-China study. Trials. 2020 Nov 11;21(1):921. doi: 10.1186/s13063-020-04741-0.
- redacted protocolLink provided by the sponsor.
- SAP\_redactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang, M.D. principal investigator
Beijing Tian Tan Hospital, Capital Medical University
Yundai Chen, M.D. principal investigator
Chinese PLA General Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Atherosclerosis, run by AstraZeneca at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.