Effects of Dengzhanxixin Capsule on Platelet Function in Individuals at High Risk for Cardiovascular Disease (FUTURE): a Multi-center, Double-blinded, Randomized, Placebo-controlled Trial

SFLX2022004

The main objective of this clinical trial is to evaluate whether the antiplatelet efficacy of the Dengzhanxixin capsule is better than that of placebo in individuals at high-risk for atherosclerotic cardiovascular disease (ASCVD).

2022-07-20

2023-12-31

2023-12-31

Recruiting

165

Inclusion Criteria: The following three conditions must be met at the same time: 1. Age \> 40 years, \< 70 years 2. Meet any of the following conditions: i) Diabetes ii) LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L iii) Hypertension; 1.8 mmol/L ≤ LDL-C \< 2.6 mmol/L or 3.1 mmol/L ≤ TC \< 4.1 mmol/L; 3 risk factors (including smoking, HDL-C \< 1.0 mmol/L, ≥ 45 years for male or ≥ 55 years for female) iv) Hypertension; 2.6mmol/L ≤ LDL-C \< 4.9mmol/L or 4.1mmol/L ≤ TC \< 7.2mmol/L; with 2 or more risk factors (same risk factors as above) 3. Sign the informed consent Exclusion Criteria: Those who meet any of the following conditions are not eligible: 1. Diagnosed ASCVD, such as coronary heart disease, stroke and peripheral vascular disease 2. Past history of heart failure 3. History of symptomatic non-traumatic intracerebral hemorrhage at any time 4. History of gastrointestinal bleeding within the past 3 months or history of major surgery within 30 days 5. Need to use anticoagulation, antiplatelet or frequent use of non-steroidal anti-inflammatory drugs 6. Have used Dengzhanxixin or preparations containing Dengzhanxixin in the past 1 month 7. Have clear adverse reactions to Dengzhanxixin in the past 8. Active liver disease, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 2 times the upper limit of normal (ULN) 9. Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/(min×1.73m2) 10. Pregnant or planning to become pregnant, or breastfeeding 11. Malignant tumors, or other serious diseases with an expected survival period of less than 1 year 12. Mental disorders or communication disorders, cognitive dysfunction, or other serious diseases that may affect participation in the study 13. Have participated in or are participating in other clinical trials in the past 1 month 14. Known poor adherence to study follow-up or study medication 15. Acute stage of disease: acute fever, acute pancreatitis, etc. In addition, subjects will be excluded from the randomization clinic if they have any of the following situations: 1. Failure to complete the lead-in treatment 2. The occurrence of placebo-related adverse reactions

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 165, 'type': 'ESTIMATED'}}

2023-07-25