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Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

Last updated on February 18, 2020

FOR MORE INFORMATION
Study Location
First People's Hospital of Fuyang City
Fuyang, Anhui, 236000 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia Coronary Artery Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02565615
Pfizer
Completed
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

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Descriptive Information
Brief Title 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
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?
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chinese cardiology patients
Condition Coronary Artery Disease, Hypercholesterolemia, Hypertension
Intervention Other: No intervention
Because this is a non-interventional study, there is no intervention here.
Study Groups/Cohorts 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
Intervention: Other: No intervention
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2019)
5115
Original Estimated Enrollment
 (submitted: September 29, 2015)
15000
Actual Study Completion Date August 31, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02565615
Other Study ID Numbers A2581197
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019

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