Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03418974
• Other study ID #: BZ1701
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 14, 2018
• Last updated: January 31, 2018
• Start date: November 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Pitavastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
• Atorvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
• Rosuvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.

Locations

Country	Name	City	State
China	Heart Center of Peking University People's Hospital	Beijing	Beijing
China	School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Jiangsu Wanbang Medicine Marketing Co., Ltd., Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood lipid parameters	The levels of total cholesterol (TC) in mmol/L	3 months
Secondary	Blood lipid parameters	The levels of triglyceride (TG) in mmol/L	3 months
Secondary	Blood lipid parameters	The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L	3 months
Secondary	Blood glucose levels	To measure the level of glycosylated hemoglobin (HbA1) in percent (%)	1 year
Secondary	Fasting blood glucose	The levels of fasting blood glucose (FBG) in mmol/L	1 year
Secondary	Blood lipid parameters	The levels of total cholesterol (TC) in mmol/L	1 year
Secondary	Blood lipid parameters	The levels of triglyceride (TG) in mmol/L	1 year
Secondary	Blood lipid parameters	The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L	1 year
Secondary	Blood lipid parameters	The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L	1 year
Secondary	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