Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Jiangsu Wanbang Medicine Marketing Co., Ltd.; Peking University People's Hospital
• Treatments: Atorvastatin; Atorvastatin Calcium; Pitavastatin; Rosuvastatin Calcium

Criteria

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.