Status:
UNKNOWN
Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Peking University People's Hospital
Jiangsu Wanbang Medicine Marketing Co., Ltd.
Conditions:
Dyslipidemias
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.
Detailed Description
Study Objective: 1. The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Ch...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
- ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
- Patients with hypertension, LDL-C \> 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C\<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; \*\*\* The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.
Exclusion
- Patients with any allergy to statins;
- ACS patients in acute stage；
- Patients with severe liver disease or biliary obstruction；
- Patients taking cyclosporine；
- Patients who have being treated with statins currently or in the past;
- Pregnant or lactating women and those women who planning to be pregnant;
- Immunodeficiency or Immunocompromised patients;
- Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
- Patients using systemic hormone drug;
- Researchers decided that the patients who was not suitable to participate in the study.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT03418974
Start Date
November 1 2017
End Date
December 31 2021
Last Update
February 1 2018
Active Locations (2)
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1
Heart Center of Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
School of Public Health, Fudan University
Shanghai, Shanghai Municipality, China, 200032