Clinical trial NCT03418974: Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia
Official title: Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyslipidemias
Keywords: Dyslipidemia
Cardiovascular Diseases
Hypertension
LDL-C
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Jiangsu Wanbang Medicine Marketing Co., Ltd.
First posted: 2018-02-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: LDL-C target achieving rate
timeFrame: 3 months
Secondary outcomes:
measure: Blood lipid parameters
timeFrame: 3 months
measure: Blood lipid parameters
timeFrame: 3 months
measure: Blood lipid parameters
timeFrame: 3 months
measure: Blood glucose levels
timeFrame: 1 year
measure: Fasting blood glucose
timeFrame: 1 year
measure: Blood lipid parameters
timeFrame: 1 year
measure: Blood lipid parameters
timeFrame: 1 year
measure: Blood lipid parameters
timeFrame: 1 year
measure: Blood lipid parameters
timeFrame: 1 year
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Heart Center of Peking University People's Hospital
state: Beijing
city: Shanghai
country: China
facility: School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Yuming Jin, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University
name: Dayi Hu, Professor
role: PRINCIPAL_INVESTIGATOR
References: