Coronary Artery Disease, Hypercholesterolemia, HypertensionATTENTIONNCT02565615
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
An observational study of Coronary Artery Disease, Hypercholesterolemia, Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in China.
Trial summary
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Hypercholesterolemia, Hypertension
- How many people
- 5,115 participants
- Where
- 54 sitesChina
- Study dates
- 22 Jun 2016to 31 Aug 2018
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese cardiology patients
Who may be able to join
- Men and women aged ≥18 years;
- Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
- Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
- Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.
Who cannot join
- Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
- Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
China54 sites
China Meitan General Hospital
Beijing, Beijing Municipality, 100028
CHINA-JAPAN Friendship Hospital
Beijing, Beijing Municipality, 100029
Fu Xing Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038
NAVY General Hospital
Beijing, Beijing Municipality, 100048
Guang'anmen hospital
Beijing, Beijing Municipality, 100053
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
The First Hospital of Fangshan District , Beijing
Beijing, Beijing Municipality, 102400
People's Hospital of Beijing Daxing District
Beijing, Beijing Municipality, 102600
Beijing Anzhen Hospital
Beijing, 100029
Peking University People's Hospital
Beijing, 100044
Hospital attached to aeromedicine institute of P.L.A (466 Hospital)
Beijing, 100089
China Meitan General Hospital
Biejing, Beijing Municipality
Chongqing Dianjiang People's Hospital
Chongqing, Chongqing Municipality, 400060
Yongchuan hospital of chongqing medical university
Chongqing, Chongqing Municipality, 402160
Chongqing Wanzhou People's Hospital
Chongqing, Chongqing Municipality, 404100
Fuling center hospital of chongqing city
Chongqing, Chongqing Municipality, 408000
Shunde people's Hospital
Foshan, Guangdong, 528300
First People's Hospital of Fuyang City
Fuyang, Anhui, 236000
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510580
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The first people's Hospital of Xiaoshan District
Hangzhou, Zhejiang China, 311200
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150030
The Peoples Hspital of Hebi City
Hebi, Henan
Huai'An First People's Hospital
Huaian, Jiangsu, 223300
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Jiaozuo City Second People's Hospital
Jiaozuo, Henan, 454001
Ji'nan Central Hospital
Jinan, Shandong, 250013
Dongyang People's Hospital
Jinhua, Zhejiang, 322100
Lanxi Municipal People's Hospital
Lanxi, Zhejiangchina, 321100
The 2nd hospital of Nanchang university
Nanchang, Jiangxi, 330006
Jiangning People's Hospital
Nanjing, Jiangsu China, 211100
Cardiology Provincial Hospital of Jiangsu Province
Nanjing, Jiangsu,china, 210024
Nanjing colleague hospital
Nanjing, Jiangsu，china, 211102
Nanjing Red Cross Hospital
Nanjing, Nanjing, Jiangsu, 210001
Ningbo First Hospital
Ningbo, Zhejiang, 315010
The Affiliated Hospital of Medical College of Ningbo University
Ningbo, Zhejiang
Puyang Oilfield General Hosipital
Puyang, Henan
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266011
Quzhou Hospital of Zhejiang University
Quzhou, Zhejiang, 324000
Ruian People's Hospital
Ruian, Zhejiang, 325200
Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine
Shanghai, Shanghai，china, 200082
Shanghai Yangpu District Central Hospital
Shanghai, 200433
Shanghai Minhang District Central Hospital
Shanghai, 201111
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110015
The Second Hospital of Hebei University
Shijiazhuang, Hebei, 050000
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, 430060
Xiamen Cardiovascular Hospital
Xiamen, Fujian, 361004
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
The first affiliated hospital of henan university of TCM
Zhengzhou, Henan
Zhengzhou No. 7 People's Hospital
Zhengzhou, Henan
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Official title: ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
- Being tested
- No intervention
- Medical subject headings
- Coronary Artery Disease, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Because this is a non-interventional study, there is no intervention here.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin dose titration (single-arm) | Judged by investigators, patients in cardiology department who are using atorvastatin can be included into this study, if they are eligible. During the study, the dose can be titrated based on the judgement of investigator Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.
Measured: 12 weeks
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: 12 weeks
Secondary outcomes (22)
Change From Baseline for Lipid Parameters at Week 12 for Overall
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.
Measured: Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Measured: Baseline to Week 12
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.
Measured: Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Measured: Baseline to Week 12
Study Drug Exposure for Overall - Total Dose and Week 12 Dose
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12
Measured: Day 1 to Week 12
Study Drug Exposure for Overall - Daily Dose
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.
Measured: Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group -Daily Dose
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Day 1 to Week 12
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.
Measured: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Adverse Events of Special Interest (AESI) for Overall
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- ALT and AST
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5%~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Precentage of Participants With Discontinuation From the Study for Overall
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.
Measured: 12 weeks of follow-up
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Measured: 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start22 Jun 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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.
- Other trials for Coronary Artery Disease, Hypercholesterolemia, HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,115 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565615
- Sponsor's protocol ID
- A2581197
- Acronym
- ATTENTION
- Status last verified
- Feb 2021
- First submitted
- 15 Sep 2015
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA
- ClinicalTrials.gov ID
- NCT02565615
- Acronym / sponsor ID
- ATTENTION / A2581197
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,115 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin dose titration (single-arm) | – | Other: No interventionJudged by investigators, patients in cardiology department who are using atorvastatin can be included into this study, if they are eligible. During the study, the dose can be titrated based on the judgement of investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese cardiology patients
Key inclusion criteria (4 listed)
- Men and women aged ≥18 years;
- Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
- Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
- Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.
Key exclusion criteria (2 listed)
- Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
- Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
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 |
|---|---|---|
| No interventionBecause this is a non-interventional study, there is no intervention here. | Other | Atorvastatin dose titration (single-arm) |
Primary outcome
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
Time frame: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
Time frame: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
22 secondary outcomes
Change From Baseline for Lipid Parameters at Week 12 for Overall
Time frame: Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
Time frame: Baseline to Week 12
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
Time frame: Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
Time frame: Baseline to Week 12
Study Drug Exposure for Overall - Total Dose and Week 12 Dose
Time frame: Day 1 to Week 12
Study Drug Exposure for Overall - Daily Dose
Time frame: Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose
Time frame: Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group -Daily Dose
Time frame: Day 1 to Week 12
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Adverse Events of Special Interest (AESI) for Overall
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level
Time frame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- ALT and AST
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Precentage of Participants With Discontinuation From the Study for Overall
Time frame: 12 weeks of follow-up
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level
Time frame: 12 weeks of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Healthy, Hypercholesterolemia
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.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, Hypercholesterolemia, Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 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 4 inclusion and 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 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?
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.