Condition coronary artery disease, hypercholesterolemia, hypertension
Treatment no intervention
Sponsor Pfizer
Start date June 2016
End date March 2018
Trial size 10000 participants
Trial identifier NCT02565615, A2581197


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。

Recruiting in the following locations…

United States No locations recruiting
Other countries China

Study Design

Observational model cohort
Time perspective prospective
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
Because this is a non-interventional study, there is no intervention here.

Primary Outcomes

The proportion of patients who achieve LDL-C goal value at 12-week atorvastatin therapy according to Chinese Guideline on Dyslipidemia Prevention and Treatment in Adult (2007 version).
time frame: 12 weeks

Secondary Outcomes

Dosage distribution of atorvastatin in patients within different risk categories as defined by Chinese Guideline on Dyslipidemia Prevention and Treatment in Adult (2007) at the end of 12-weeks
time frame: 12 weeks
The percentage of patients who dropout and reason
time frame: up to 12 weeks
The proportion of patients who present with muscle related adverse event
time frame: up to 12 weeks
The proportion of patients who present with persistent elevation of liver enzyme
time frame: up to 12 weeks
The proportion of patients who present with major adverse cardiovascular events
time frame: up to 12 weeks

Eligibility Criteria

All participants at least 18 years old.

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. - 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

Additional Information

Official title Atorvastatin Effectiveness And Safety In Cardiology Patients In Real World Setting: A Registry Study In China
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Pfizer.