Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting (ATTENTION)

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。

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease, Hypercholesterolemia, Hypertension
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 5115

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100089
    • Hospital attached to aeromedicine institute of P.L.A (466 Hospital)
  • Shanghai, China, 200433
    • Shanghai Yangpu District Central Hospital
  • Shanghai, China, 201111
    • Shanghai Minhang District Central Hospital
  • Anhui
    • Fuyang, Anhui, China, 236000
      • First People's Hospital of Fuyang City
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China, 100053
      • Guang'anmen hospital
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100028
      • China Meitan General Hospital
    • Beijing, Beijing, China, 100048
      • Navy General Hospital
    • Beijing, Beijing, China, 100038
      • Fu Xing Hospital Affiliated to Capital Medical University
    • Beijing, Beijing, China, 102400
      • The First Hospital of Fangshan District , Beijing
    • Beijing, Beijing, China, 102600
      • People's Hospital of Beijing Daxing District
    • Biejing, Beijing, China
      • China Meitan General Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 408000
      • Fuling Center Hospital of Chongqing City
    • Chongqing, Chongqing, China, 400060
      • Chongqing Dianjiang People's Hospital
    • Chongqing, Chongqing, China, 402160
      • Yongchuan Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 404100
      • Chongqing Wanzhou People's Hospital
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Xiamen Cardiovascular Hospital
  • Guangdong
    • Foshan, Guangdong, China, 528300
      • Shunde People's Hospital
    • Guangzhou, Guangdong, China
      • The Fifth Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510580
      • The First Affiliated Hospital of Guangdong Pharmaceutical University
    • Jiangmen, Guangdong, China, 529000
      • JiangMen Central Hospital
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The second Hospital Of Hebei University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150030
      • Heilongjiang provincial hospital
  • Henan
    • Hebi, Henan, China
      • The Peoples Hspital of Hebi City
    • Jiaozuo, Henan, China, 454001
      • Jiaozuo City Second People's Hospital
    • Puyang, Henan, China
      • Puyang Oilfield General Hosipital
    • Zhengzhou, Henan, China
      • The first affiliated hospital of henan university of TCM
    • Zhengzhou, Henan, China, 450000
      • HeNan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Zhengzhou No. 7 People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Wuhan University - Renmin Hospital (Hubei General Hospital)
  • Jiangsu
    • Huaian, Jiangsu, China, 223300
      • Huai'an First People's Hospital
    • Taizhou, Jiangsu, China, 225300
      • Jiangsu Taizhou People's Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Jiangsu China
    • Nanjing,, Jiangsu China, China, 211100
      • Jiangning People's Hospital
  • Jiangsu,china
    • Nanjing, Jiangsu,china, China, 210024
      • Cardiology Provincial Hospital of Jiangsu Province
  • Jiangsu，china
    • Nanjing, Jiangsu，china, China, 211102
      • Nanjing colleague hospital
  • Jiangxi
    • NanChang, Jiangxi, China, 330006
      • The 2nd hospital of Nanchang university
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • The General Hospital of Shenyang Military
  • Nanjing, Jiangsu
    • Nanjing, Nanjing, Jiangsu, China, 210001
      • Nanjing Red Cross Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Ji'nan Central Hospital
    • Qingdao, Shandong, China, 266011
      • The Affiliated Hospital of Qingdao University
  • Shanghai，china
    • Shanghai, Shanghai，china, China, 200082
      • Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine
  • Shanxi
    • Taiyuan, Shanxi, China, 030024
      • Shanxi Cardiovascular Hospital
  • Zhejiang
    • Jinhua, Zhejiang, China, 322100
      • Dongyang People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
    • Ningbo, Zhejiang, China
      • The Affiliated Hospital of Medical College of Ningbo University
    • Quzhou, Zhejiang, China, 324000
      • Quzhou Hospital of Zhejiang University
    • Ruian, Zhejiang, China, 325200
      • Ruian People's Hospital
  • Zhejiang China
    • Hangzhou, Zhejiang China, China, 311200
      • The first people's Hospital of Xiaoshan District
  • Zhejiangchina
    • Lanxi, Zhejiangchina, China, 321100
      • Lanxi Municipal People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese cardiology patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: No intervention; Because this is a non-interventional study, there is no intervention here.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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 )
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 )
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2016
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Coronary Artery Disease; Hypercholesterolemia
• Other Study ID Numbers: A2581197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No