Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Phase 4

• Conditions: Dyslipidemias
• Interventions: Drug: Pitavastatin; Drug: Atorvastatin; Drug: Rosuvastatin

• Registration Number: NCT03418974
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-14
• Study First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin treatment	Pitavastatin	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..
Atorvastatin treatment	Atorvastatin	The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.
Rosuvastatin treatment	Rosuvastatin	The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood lipid parameters	1 year	The levels of High density lipoprotein cholesterol (HDL-C) 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.

Trial Locations

Locations (2)

School of Public Health, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Heart Center of Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China