Cardiovascular Disease (Populations at High Risk of Atherosclerosis/Vascular Calcification)
Conditions
Interventions
Test group:Participants in the test substance group received one capsule of vitamin K2 daily for 24 consecutive weeks.
Placebo group:Participants in the placebo group received one capsule of placebo orally per day for 24 consecutive weeks.
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 35–70 years, male or female; 2. Classified as having moderate-to-high risk of cardiovascular disease according to the China-PAR (Prediction for ASCVD Risk in China) risk assessment model; 3.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any of the following cardiovascular diseases: (1).Coronary artery disease (including stable/unstable angina, myocardial infarction, post-percutaneous coronary intervention or coronary artery bypass grafting); (2).Ischemic or hemorrhagic stroke; (3).Heart failure (New York Heart Association [NYHA] functional class >= II); (4).Peripheral artery disease (e.g., intermittent claudication, ankle-brachial index [ABI] < 0.9); (5).Major arrhythmias (e.g., persistent atrial fibrillation, ventricular tachycardia, third-degree atrioventricular block); (6).History of aortic aneurysm or dissection; (7).Other severe cardiovascular diseases deemed by the investigator to potentially affect the study outcomes; 2. Known bleeding disorders or current use of anticoagulant therapy (e.g., warfarin); 3. Diagnosed diabetes mellitus; 4.Current use of the following medications: (1).Calcium channel blockers (CCBs) (e.g., amlodipine besylate, nifedipine, felodipine); (2).Angiotensin-converting enzyme inhibitors (ACEIs) (e.g., captopril, enalapril, benazepril); (3).Angiotensin II receptor blockers (ARBs) (e.g., valsartan, irbesartan, telmisartan); (4).Diuretics (e.g., hydrochlorothiazide, indapamide); (5).Beta-blockers (e.g., metoprolol, bisoprolol); (6).Statins (e.g., atorvastatin, rosuvastatin); (7).Cholesterol absorption inhibitors (e.g., ezetimibe); (8).Fibrates (e.g., fenofibrate, bezafibrate). 5. Pregnant or breastfeeding women, or women planning to become pregnant during the study period; 6.Severe cardiac, hepatic, or renal insufficiency; malignant tumors; or mental disorders; 7. Known or suspected hypersensitivity to vitamin K2 or any of its excipients; 8. Current use of dietary supplements containing vitamin K2; 9. Participation in another interventional clinical trial within 1 month prior to screening; 10. History of alcohol or drug abuse within 1 year prior to screening; 11. Poor compliance as judged by the investigator, or any other condition deemed by the investigator to make the participant unsuitable for enrollment in this trial.;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncarboxylated Matrix Gla Protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Carotid Intima-Media Thickness;Blood Pressure (BP);Uncarboxylated Osteocalcin;Plasma Untargeted Metabolomics Analysis; | — |
Countries
China
Contacts
Public ContactZhang Jianwei
Suzhou Municipal Hospital
Outcome results
None listed