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
1 other identifier
observational
5,115
1 country
54
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。
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
June 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
November 4, 2019
CompletedFebruary 21, 2021
February 1, 2021
2.2 years
September 15, 2015
August 14, 2019
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (22)
Change From Baseline for Lipid Parameters at Week 12 for Overall
Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
Baseline to Week 12
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
Baseline to Week 12
Study Drug Exposure for Overall - Total Dose and Week 12 Dose
Day 1 to Week 12
- +17 more secondary outcomes
Study Arms (1)
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
Interventions
Because this is a non-interventional study, there is no intervention here.
Eligibility Criteria
Chinese cardiology patients
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
First People's Hospital of Fuyang City
Fuyang, Anhui, 236000, China
China Meitan General Hospital
Beijing, Beijing Municipality, 100028, China
CHINA-JAPAN Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Fu Xing Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038, China
NAVY General Hospital
Beijing, Beijing Municipality, 100048, China
Guang'anmen hospital
Beijing, Beijing Municipality, 100053, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
The First Hospital of Fangshan District , Beijing
Beijing, Beijing Municipality, 102400, China
People's Hospital of Beijing Daxing District
Beijing, Beijing Municipality, 102600, China
China Meitan General Hospital
Biejing, Beijing Municipality, China
Chongqing Dianjiang People's Hospital
Chongqing, Chongqing Municipality, 400060, China
Yongchuan hospital of chongqing medical university
Chongqing, Chongqing Municipality, 402160, China
Chongqing Wanzhou People's Hospital
Chongqing, Chongqing Municipality, 404100, China
Fuling center hospital of chongqing city
Chongqing, Chongqing Municipality, 408000, China
Xiamen Cardiovascular Hospital
Xiamen, Fujian, 361004, China
Shunde people's Hospital
Foshan, Guangdong, 528300, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510580, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
The Second Hospital of Hebei University
Shijiazhuang, Hebei, 050000, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150030, China
The Peoples Hspital of Hebi City
Hebi, Henan, China
Jiaozuo City Second People's Hospital
Jiaozuo, Henan, 454001, China
Puyang Oilfield General Hosipital
Puyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
The first affiliated hospital of henan university of TCM
Zhengzhou, Henan, China
Zhengzhou No. 7 People's Hospital
Zhengzhou, Henan, China
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, 430060, China
Huai'An First People's Hospital
Huaian, Jiangsu, 223300, China
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Jiangning People's Hospital
Nanjing, Jiangsu China, 211100, China
Cardiology Provincial Hospital of Jiangsu Province
Nanjing, Jiangsu,china, 210024, China
Nanjing colleague hospital
Nanjing, Jiangsu，china, 211102, China
The 2nd hospital of Nanchang university
Nanchang, Jiangxi, 330006, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110015, China
Nanjing Red Cross Hospital
Nanjing, Nanjing, Jiangsu, 210001, China
Ji'nan Central Hospital
Jinan, Shandong, 250013, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266011, China
Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine
Shanghai, Shanghai，china, 200082, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
Dongyang People's Hospital
Jinhua, Zhejiang, 322100, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
The Affiliated Hospital of Medical College of Ningbo University
Ningbo, Zhejiang, China
Quzhou Hospital of Zhejiang University
Quzhou, Zhejiang, 324000, China
Ruian People's Hospital
Ruian, Zhejiang, 325200, China
The first people's Hospital of Xiaoshan District
Hangzhou, Zhejiang China, 311200, China
Lanxi Municipal People's Hospital
Lanxi, Zhejiangchina, 321100, China
Beijing Anzhen Hospital
Beijing, 100029, China
Peking University People's Hospital
Beijing, 100044, China
Hospital attached to aeromedicine institute of P.L.A (466 Hospital)
Beijing, 100089, China
Shanghai Yangpu District Central Hospital
Shanghai, 200433, China
Shanghai Minhang District Central Hospital
Shanghai, 201111, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The limitations of the study are intrinsic to its observational, non-controlled, non-randomized design. This study stopped enrollment prior to meeting the planned sample size and was not committed to submit to China agency.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
October 1, 2015
Study Start
June 22, 2016
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
February 21, 2021
Results First Posted
November 4, 2019
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
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.