Dyslipidemia or atherosclerosis
Conditions
Interventions
Experimental group:Take pivastatin calcium Dispersible tablets (4mg/ day) orally every day for treatment
Control group:Oral rosuvastatin calcium tablets (10mg/ day) are taken daily for treatment
Sponsors
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Provincial People's Hospital.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male or female individuals aged 18 to 65 years old (including the critical value). (2) Those diagnosed with dyslipidemia/atherosclerosis and requiring oral statins. (3) Before the study, the subjects should have a thorough understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of this project, understand the research procedures, be able to complete the follow-up as required and sign the informed consent form in person.
Exclusion criteria
Exclusion criteria: (1) Patients with severe diseases of important organ systems such as the heart, brain, lungs, liver, gallbladder, kidneys, blood, and muscles, or with inflammatory diseases such as lupus erythematosus, rheumatoid arthritis, overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease, who the researchers consider unsuitable to participate in this study. (2) It is known that there are currently active or recurrent severe infections such as active tuberculosis; Chronic infection of hepatitis B virus (HBV) or hepatitis C HCV There is a history of human immunodeficiency virus (HIV) infection. (3) Suffering from malignant tumors or having a history of malignant tumors within 5 years prior to screening. (4) There is a history of major organ transplantation or hematopoietic stem cell/bone marrow transplantation. (5) Patients with any of the following laboratory test abnormalities during screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >=2 times the upper limit of normal (ULN) or creatine kinase (CK)>=2 times ULN. Note: If the laboratory test results during the screening period are abnormal, a repeated test can be conducted within the 4-week screening period to confirm the abnormal results. If the results return to normal within the 4-week screening period, the subjects can enter the study. (6) Patients who have received statin treatment during the screening period or one month before administration or within five half-lives of the drug (whichever is longer). (7) During the screening period or one month before administration, or within five half-lives of the drug (whichever is longer), or when it is planned to take drugs that may interact with statins during the study period, This includes cyclosporine, azole antifungal drugs (such as itraconazole, ketoconazole), macrolide antiinfective drugs (such as erythromycin, clarithromycin, terithromycin), fibrate lipid-regulating drugs (such as gefebate, benzabiate), and HIV Patients with protease inhibitors (such as lopinavir, darunavir, ritonavir), tacrolimus, everolimus, sirolimus, niacin, nefazolidone, cyclosporine, amiodarone, diltiazem, fusitic acid, colchicine, etc. (8) Patients with a previous allergy history to the ingredients of the test preparation. (9) People with congenital immune deficiency or congenital low immunity. (10) Patients who are addicted to drugs, alcohol, or have mental disorders, are unable to cooperate or adhere to treatment, or have poor compliance. (11) Men or women who are pregnant or breastfeeding, or have plans to have children within the last six months. (12) Those who have received inactivated vaccines within two weeks before entering clinical research or attenuated live vaccines within three months before entering clinical research, or plan to receive vaccines during the research period. (13) Patients who are simultaneously participating in other clinical studies. (14) Any researcher who, for any other reason, deems it inappropriate to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in proportions of immune cell subsets;Changes in the expression of related proteins and metabolic levels.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory testing;Changes in levels of serum effector cytokines; | — |
Countries
China
Contacts
Public ContactHaoyu Meng
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
Outcome results
None listed