Atherosclerotic cardiovascular disease intermediate risk population
Conditions
Interventions
Experimental Group (Xuezhikang Capsules Group):Intensified lifestyle advice and Xuezhikang Capsules
Control Group (Placebo Group):Intensified lifestyle advice and placebo
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 80 years; (2) Participants assessed as having intermediate 10-year ASCVD risk according to the Chinese Guidelines for Lipid Management (2023) meets any of the following conditions: 1) Participants without hypertension and with 2 risk factors, combined with 3.4mmol/L=LDL-C<4.9mmol/L or 5.2mmol/L=TC<7.2mmol/L; 2) Participants without hypertension and with 3 risk factors, combined with 2.6mmol/L=LDL-C<4.9mmol/L or 4.1mmol/L=TC<7.2mmol/L; 3) Participants with hypertension and 1 risk factors, combined with 2.6mmol/L=LDL-C<4.9mmol/L or 4.1mmol/L=TC<7.2mmol/L; 4) Participants with hypertension and 2 risk factors, combined with 1.8mmol/L=LDL-C<2.6mmol/L or 3.1mmol/L=TC<4.1mmol/L; (3) Not pregnant or planning to become pregnant; (4) Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Diabetic patients at high risk of ASCVD; (2) Stage 3–5 chronic kidney disease patients; (3)History of atherosclerotic cardiovascular disease, including coronary heart disease, coronary artery or other vascular revascularization procedures, atherosclerosis-induced stroke or TIA, and atherosclerosis-induced peripheral artery disease; (4) Participants who had a cerebrovascular accident, severe trauma, or major surgery within 6 months prior to the screening period; (5) Genetic dyslipidemias; (6) Combined with other diseases may cause dyslipidemia; (7) Dyslipidemia caused by medications; (8) History of use of nucleic acid-based lipid-lowering drugs; (9) Participants who used any of the following lipid metabolism-altering drugs within 4 weeks prior to screening: statins, cholesterol absorption inhibitors, PCSK9 inhibitors, probucol, bile acid sequestrants, other major cholesterol-lowering lipid-regulating drugs (e.g., Lipidil, multivastatin, etc.), fibrates, niacin, high-purity fish oil formulations, microsomal TG transfer protein inhibitors, apolipoprotein B100 synthesis inhibitors, angiopoietin-like protein 3 inhibitors, ApoC3 inhibitors, lipid-lowering traditional Chinese medicines or formulations, etc.; (10) Non-cardiovascular comorbidities with life expectancy 3×ULN; 2) CK >2.5×ULN; (14) Allergy to study drug; (15) Breastfeeding women; (16) Participants who are participating in other clinical trials (excluding vitamins and minerals) and receiving investigational treatment; (17) Investigators consider unsuitable for participants selected for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low-Density Lipoprotein Cholesterol (LDL-C); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Cholesterol (TC);Triglycerides (TG);High-Density Lipoprotein (HDL-C);Apolipoprotein A1 (ApoA1);Apolipoprotein B (ApoB);Lipoprotein(a) (Lp(a));Carotid intima-media thickness (CIMT);Pulse Wave Velocity (PWV);Ankle-Brachial Index (ABI);Cardio-cerebrovascular events;All-cause mortality;Brachial artery flow-mediated vasodilation function (FMD); | — |
Countries
China
Contacts
Public ContactBo Yu
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed