Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
NCT02565615
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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.
- 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
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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 | 5115 | ||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | February 2021 | ||||