Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

Coronary Artery Disease, Hypercholesterolemia, Hypertension Clinical Trial

— ATTENTION  

Official title:

ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565615
• Other study ID #: A2581197
• Status: Completed
• Start date: June 22, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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。

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5115
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease, Hypercholesterolemia, Hypertension
• Hypercholesterolemia

Intervention

Other:
• No intervention
Because this is a non-interventional study, there is no intervention here.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	China Meitan General Hospital	Beijing	Beijing
China	CHINA-JAPAN Friendship Hospital	Beijing	Beijing
China	Fu Xing Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Guang'anmen hospital	Beijing	Beijing
China	Hospital attached to aeromedicine institute of P.L.A (466 Hospital)	Beijing
China	NAVY General Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	People's Hospital of Beijing Daxing District	Beijing	Beijing
China	The First Hospital of Fangshan District , Beijing	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	China Meitan General Hospital	Biejing	Beijing
China	Chongqing Dianjiang People's Hospital	Chongqing	Chongqing
China	Chongqing Wanzhou People's Hospital	Chongqing	Chongqing
China	Fuling center hospital of chongqing city	Chongqing	Chongqing
China	Yongchuan hospital of chongqing medical university	Chongqing	Chongqing
China	Shunde people's Hospital	Foshan	Guangdong
China	First People's Hospital of Fuyang City	Fuyang	Anhui
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong
China	The first people's Hospital of Xiaoshan District	Hangzhou	Zhejiang China
China	Heilongjiang Provincial Hospital	Harbin	Heilongjiang
China	The Peoples Hspital of Hebi City	Hebi	Henan
China	Huai'An First People's Hospital	Huaian	Jiangsu
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Jiaozuo City Second People's Hospital	Jiaozuo	Henan
China	Ji'nan Central Hospital	Jinan	Shandong
China	Dongyang People's Hospital	Jinhua	Zhejiang
China	Lanxi Municipal People's Hospital	Lanxi	Zhejiangchina
China	The 2nd hospital of Nanchang university	NanChang	Jiangxi
China	Cardiology Provincial Hospital of Jiangsu Province	Nanjing	Jiangsu,china
China	Nanjing colleague hospital	Nanjing	Jiangsu,china
China	Nanjing Red Cross Hospital	Nanjing	Nanjing, Jiangsu
China	Jiangning People's Hospital	Nanjing,	Jiangsu China
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of Medical College of Ningbo University	Ningbo	Zhejiang
China	Puyang Oilfield General Hosipital	Puyang	Henan
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Quzhou Hospital of Zhejiang University	Quzhou	Zhejiang
China	Ruian People's Hospital	Ruian	Zhejiang
China	Shanghai Minhang District Central Hospital	Shanghai
China	Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine	Shanghai	Shanghai,china
China	Shanghai Yangpu District Central Hospital	Shanghai
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	The Second Hospital of Hebei University	Shijiazhuang	Hebei
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu
China	Wuhan University - Renmin Hospital (Hubei General Hospital)	Wuhan	Hubei
China	Xiamen Cardiovascular Hospital	Xiamen	Fujian
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The first affiliated hospital of henan university of TCM	Zhengzhou	Henan
China	Zhengzhou No. 7 People's Hospital	Zhengzhou	Henan
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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	Day 1 to Week 12
Secondary	Study Drug Exposure for Overall - Daily Dose	Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.	Day 1 to Week 12
Secondary	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.	Day 1 to Week 12
Secondary	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.	Day 1 to Week 12
Secondary	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.	Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Secondary	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.	Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Secondary	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.	Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Secondary	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.	12 weeks of follow-up
Secondary	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.	12 weeks of follow-up

External Links

•   To obtain contact information for a study center near you, click here.