Dyslipidemias
Conditions
Keywords
Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C
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 Chinese population; 2. The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients. Study Design: The study was an open-label, multi-center network register-based follow-up study. The total sample size: 10000 participants.
Interventions
DRUGPitavastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
DRUGAtorvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
DRUGRosuvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.
Sponsors
Peking University People's Hospital
Jiangsu Wanbang Medicine Marketing Co., Ltd.
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are assigned to one of two or more groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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). 2. 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; 3. 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 criteria
1. Patients with any allergy to statins; 2. ACS patients in acute stage； 3. Patients with severe liver disease or biliary obstruction； 4. Patients taking cyclosporine； 5. Patients who have being treated with statins currently or in the past; 6. Pregnant or lactating women and those women who planning to be pregnant; 7. Immunodeficiency or Immunocompromised patients; 8. Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy); 9. Patients using systemic hormone drug; 10. Researchers decided that the patients who was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C target achieving rate | 3 months | To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood lipid parameters | 3 months | The levels of total cholesterol (TC) in mmol/L |
| Blood glucose levels | 1 year | To measure the level of glycosylated hemoglobin (HbA1) in percent (%) |
| Fasting blood glucose | 1 year | The levels of fasting blood glucose (FBG) in mmol/L |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through study completion, an average of 1 year | To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study. |
Countries
China
Outcome results
None listed