Clinical trial NCT02565615: Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
Official title: ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease, Hypercholesterolemia, Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 5115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese cardiology patients

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。


Eligibility criteria: 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

Primary outcomes:
measure: Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
timeFrame: 12 weeks
measure: Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline for Lipid Parameters at Week 12 for Overall
timeFrame: Baseline to Week 12
measure: Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
timeFrame: Baseline to Week 12
measure: Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
timeFrame: Baseline to Week 12
measure: Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
timeFrame: Baseline to Week 12
measure: Study Drug Exposure for Overall - Total Dose and Week 12 Dose
timeFrame: Day 1 to Week 12
measure: Study Drug Exposure for Overall - Daily Dose
timeFrame: Day 1 to Week 12
measure: Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose
timeFrame: Day 1 to Week 12
measure: Study Drug Exposure Within Each CVD Risk Group -Daily Dose
timeFrame: Day 1 to Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall
timeFrame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level
timeFrame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
measure: Number of Participants With Adverse Events of Special Interest (AESI) for Overall
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
measure: Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level
timeFrame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk
timeFrame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory Overall- ALT and AST
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory Overall- Creatine Kinase
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase
timeFrame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
measure: Precentage of Participants With Discontinuation From the Study for Overall
timeFrame: 12 weeks of follow-up
measure: Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level
timeFrame: 12 weeks of follow-up
Other outcomes:
Locations:
city: Fuyang
country: China
facility: First People's Hospital of Fuyang City
state: Anhui
city: Beijing
country: China
facility: China Meitan General Hospital
state: Beijing
city: Beijing
country: China
facility: CHINA-JAPAN Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Fu Xing Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: NAVY General Hospital
state: Beijing
city: Beijing
country: China
facility: Guang'anmen hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The First Hospital of Fangshan District , Beijing
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Beijing Daxing District
state: Beijing
city: Biejing
country: China
facility: China Meitan General Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Dianjiang People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Yongchuan hospital of chongqing medical university
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Wanzhou People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Fuling center hospital of chongqing city
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital
state: Fujian
city: Foshan
country: China
facility: Shunde people's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei University
state: Hebei
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Hebi
country: China
facility: The Peoples Hspital of Hebi City
state: Henan
city: Jiaozuo
country: China
facility: Jiaozuo City Second People's Hospital
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hosipital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The first affiliated hospital of henan university of TCM
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou No. 7 People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan University - Renmin Hospital (Hubei General Hospital)
state: Hubei
city: Nanjing,
country: China
facility: Jiangning People's Hospital
state: Jiangsu China
city: Nanjing
country: China
facility: Cardiology Provincial Hospital of Jiangsu Province
state: Jiangsu,china
city: Huaian
country: China
facility: Huai'An First People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing colleague hospital
state: Jiangsu，china
city: NanChang
country: China
facility: The 2nd hospital of Nanchang university
state: Jiangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
state: Liaoning
city: Nanjing
country: China
facility: Nanjing Red Cross Hospital
state: Nanjing, Jiangsu
city: Jinan
country: China
facility: Ji'nan Central Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine
state: Shanghai，china
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The first people's Hospital of Xiaoshan District
state: Zhejiang China
city: Lanxi
country: China
facility: Lanxi Municipal People's Hospital
state: Zhejiangchina
city: Jinhua
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated Hospital of Medical College of Ningbo University
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou Hospital of Zhejiang University
state: Zhejiang
city: Ruian
country: China
facility: Ruian People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Hospital attached to aeromedicine institute of P.L.A (466 Hospital)
city: Shanghai
country: China
facility: Shanghai Yangpu District Central Hospital
city: Shanghai
country: China
facility: Shanghai Minhang District Central Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: