Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Hypertension
- Registration Number
- NCT02565615
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief 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。
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5115
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall 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 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline for Lipid Parameters at Week 12 for Overall Baseline to Week 12 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.
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall Baseline to Week 12 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.
Number of Participants With Adverse Events of Special Interest (AESI) for Overall Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16) 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.
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Study Drug Exposure for Overall - Total Dose and Week 12 Dose Day 1 to Week 12 Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ) 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.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16) 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.
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level 12 weeks of follow-up 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.
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Baseline to Week 12 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.
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Baseline to Week 12 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.
Study Drug Exposure for Overall - Daily Dose Day 1 to Week 12 Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Day 1 to Week 12 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.
Study Drug Exposure Within Each CVD Risk Group -Daily Dose Day 1 to Week 12 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.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ) 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.
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Change From Baseline for Clinical Laboratory Overall- ALT and AST Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) 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.
Precentage of Participants With Discontinuation From the Study for Overall 12 weeks of follow-up Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.
Trial Locations
- Locations (53)
First People's Hospital of Fuyang City
🇨🇳Fuyang, Anhui, China
China Meitan General Hospital
🇨🇳Biejing, Beijing, China
CHINA-JAPAN Friendship Hospital
🇨🇳Beijing, Beijing, China
Fu Xing Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
NAVY General Hospital
🇨🇳Beijing, Beijing, China
Guang'anmen hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The First Hospital of Fangshan District , Beijing
🇨🇳Beijing, Beijing, China
People's Hospital of Beijing Daxing District
🇨🇳Beijing, Beijing, China
Chongqing Dianjiang People's Hospital
🇨🇳Chongqing, Chongqing, China
Scroll for more (43 remaining)First People's Hospital of Fuyang City🇨🇳Fuyang, Anhui, China