Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Study Overview
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Brief Summary
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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
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Study Objective: 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; 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.

Official Title
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Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Atorvastatin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin treatment<br>The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd.. | Drug: Pitavastatin<br>* Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.<br>|
| Experimental: Atorvastatin treatment<br>The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. | Drug: Atorvastatin<br>* Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.<br>|
| Experimental: Rosuvastatin treatment<br>The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. | Drug: Rosuvastatin<br>* Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C target achieving rate | To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid parameters | The levels of total cholesterol (TC) in mmol/L | 3 months | 
| Blood lipid parameters | The levels of triglyceride (TG) in mmol/L | 3 months | 
| Blood lipid parameters | The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L | 3 months | 
| Blood glucose levels | To measure the level of glycosylated hemoglobin (HbA1) in percent (%) | 1 year | 
| Fasting blood glucose | The levels of fasting blood glucose (FBG) in mmol/L | 1 year | 
| Blood lipid parameters | The levels of total cholesterol (TC) in mmol/L | 1 year | 
| Blood lipid parameters | The levels of triglyceride (TG) in mmol/L | 1 year | 
| Blood lipid parameters | The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L | 1 year | 
| Blood lipid parameters | The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L | 1 year | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C