Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

NCT ID: NCT02565615

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-22

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease, Hypercholesterolemia, Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No intervention

Intervention Type OTHER

Because this is a non-interventional study, there is no intervention here.

Interventions

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No intervention

Because this is a non-interventional study, there is no intervention here.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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First People's Hospital of Fuyang City

Fuyang, Anhui, China

Site Status

China Meitan General Hospital

Beijing, Beijing Municipality, China

Site Status

CHINA-JAPAN Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Fu Xing Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status

NAVY General Hospital

Beijing, Beijing Municipality, China

Site Status

Guang'anmen hospital

Beijing, Beijing Municipality, China

Site Status

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Hospital of Fangshan District , Beijing

Beijing, Beijing Municipality, China

Site Status

People's Hospital of Beijing Daxing District

Beijing, Beijing Municipality, China

Site Status

China Meitan General Hospital

Biejing, Beijing Municipality, China

Site Status

Chongqing Dianjiang People's Hospital

Chongqing, Chongqing Municipality, China

Site Status

Yongchuan hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

Site Status

Chongqing Wanzhou People's Hospital

Chongqing, Chongqing Municipality, China

Site Status

Fuling center hospital of chongqing city

Chongqing, Chongqing Municipality, China

Site Status

Xiamen Cardiovascular Hospital

Xiamen, Fujian, China

Site Status

Shunde people's Hospital

Foshan, Guangdong, China

Site Status

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Site Status

The Second Hospital of Hebei University

Shijiazhuang, Hebei, China

Site Status

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

Site Status

The Peoples Hspital of Hebi City

Hebi, Henan, China

Site Status

Jiaozuo City Second People's Hospital

Jiaozuo, Henan, China

Site Status

Puyang Oilfield General Hosipital

Puyang, Henan, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

The first affiliated hospital of henan university of TCM

Zhengzhou, Henan, China

Site Status

Zhengzhou No. 7 People's Hospital

Zhengzhou, Henan, China

Site Status

Wuhan University - Renmin Hospital (Hubei General Hospital)

Wuhan, Hubei, China

Site Status

Huai'An First People's Hospital

Huaian, Jiangsu, China

Site Status

Jiangsu Taizhou People's Hospital

Taizhou, Jiangsu, China

Site Status

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status

Jiangning People's Hospital

Nanjing, Jiangsu China, China

Site Status

Cardiology Provincial Hospital of Jiangsu Province

Nanjing, Jiangsu,china, China

Site Status

Nanjing colleague hospital

Nanjing, Jiangsu,china, China

Site Status

The 2nd hospital of Nanchang university

Nanchang, Jiangxi, China

Site Status

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

Site Status

Nanjing Red Cross Hospital

Nanjing, Nanjing, Jiangsu, China

Site Status

Ji'nan Central Hospital

Jinan, Shandong, China

Site Status

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine

Shanghai, Shanghai,china, China

Site Status

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Site Status

Dongyang People's Hospital

Jinhua, Zhejiang, China

Site Status

Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status

The Affiliated Hospital of Medical College of Ningbo University

Ningbo, Zhejiang, China

Site Status

Quzhou Hospital of Zhejiang University

Quzhou, Zhejiang, China

Site Status

Ruian People's Hospital

Ruian, Zhejiang, China

Site Status

The first people's Hospital of Xiaoshan District

Hangzhou, Zhejiang China, China

Site Status

Lanxi Municipal People's Hospital

Lanxi, Zhejiangchina, China

Site Status

Beijing Anzhen Hospital

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

Hospital attached to aeromedicine institute of P.L.A (466 Hospital)

Beijing, , China

Site Status

Shanghai Yangpu District Central Hospital

Shanghai, , China

Site Status

Shanghai Minhang District Central Hospital

Shanghai, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A2581197

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

Other Identifiers

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A2581197

Identifier Type: -

Identifier Source: org_study_id

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