Atherosclerotic Cardiovascular Disease
Conditions
Interventions
Experimental Group A:A combination therapy regimen was adopted. The standard treatment consists of oral colchicine tablets (0.5 mg, once daily), in combination with oral Usufu? (ursodeoxycholic acid c
Experimental Group B:A combination therapy regimen was adopted. The standard treatment consisted of oral colchicine tablets (0.5 mg,qd), combined with oral Miya? (live Clostridium butyricum tablets) (
Control group C:A monotherapy regimen was adopted. Patients were prescribed only the standard-of-care drug colchicine tablets (0.5 mg,qd), and were not given Usuf, Miya or any placebo.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age and gender: Aged between 18 and 75; no restrictions on gender. 2.Disease diagnosis:Patients clinically diagnosed with atherosclerotic cardiovascular disease (ASCVD). 3.Informed consent: Participants who voluntarily agree to participate in this study and are able to understand and sign the informed consent form. 4.Compliance: Participants with good compliance who are able to complete two outpatient follow-up visits and take the study medication at home during the study period.
Exclusion criteria
Exclusion criteria: 1.Severe organ dysfunction: Participants with a short expected survival time, or with severe cardiac, hepatic, or renal dysfunction, including eGFR 3 times the upper limit of normal. 2.Gastrointestinal diseases: Participants with inflammatory bowel disease, short bowel syndrome, or malabsorption syndrome; a history of severe chronic diarrhea or recent acute diarrhea within 2 weeks; or complete biliary obstruction. 3.Drug allergy and contraindications: Participants who are allergic to colchicine, ursodeoxycholic acid, Clostridium butyricum, or any of their excipients, such as lactose. 4.Use of interfering medications:Participants who have used any antibiotics, antifungal agents, or probiotic preparations within 4 weeks before enrollment. Participants who have used other bile acid medications, such as tauroursodeoxycholic acid or chenodeoxycholic acid, within 4 weeks before enrollment.Participants who are currently taking strong P-gp or CYP3A4 inhibitors, such as clarithromycin, ketoconazole, or cyclosporine. 5.Special populations: Women who are pregnant or planning pregnancy; participants with impaired consciousness or inability to live independently. 6.Other conditions judged by the study physician: Any physical or psychological disease or condition that, in the opinion of the study physician, may increase study-related risks, affect the participant’s adherence to the study protocol, or affect the participant’s ability to complete the study; or any other condition that the investigator considers unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Colchicine Concentration;Blood Colchicine Concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative Abundance of Gut Bile Salt Hydrolase (BSH) Gene;Plasma high-sensitivity C-reactive protein;Laboratory Safety Parameters for Liver and Kidney Function;Incidence of Adverse Events;Plasma Bile Acid Metabolic Profile;Fecal Bile Acid Metabolic Profile; | — |
Countries
China
Contacts
Public ContactYao Kang
Zhongshan Hospital, Fudan University
Outcome results
None listed