Evaluating Dengzhanxixin Capsule's effects on platelet function in high-risk cardiovascular patients

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

This study is testing whether Dengzhanxixin capsules can help prevent blood clots in people aged 40 to 70 who are at high risk for heart problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (ShenZhen, ShenZhen)
• Trial ID: NCT05459519 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the antiplatelet efficacy of Dengzhanxixin capsules compared to a placebo in individuals at high risk for atherosclerotic cardiovascular disease (ASCVD). The study will recruit 165 participants aged 40 to 70 who meet specific criteria related to diabetes, hypertension, or cholesterol levels. Participants will receive either the Dengzhanxixin capsule or a placebo over a 10-week follow-up period. The trial is designed to determine the safety and effectiveness of this traditional Chinese medicine in preventing cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 40 to 70 with diabetes, hypertension, or elevated cholesterol levels who are at high risk for ASCVD.

Not a fit: Patients with a history of diagnosed ASCVD, heart failure, or recent major bleeding events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for individuals at high risk for cardiovascular disease.

How similar studies have performed: Previous studies have shown positive results with Dengzhanxixin capsules in related conditions, but this specific application in high-risk ASCVD patients is novel.

Eligibility criteria

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

Where this trial is running

ShenZhen, ShenZhen

• Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen — ShenZhen, ShenZhen, China (Recruiting)

Study contacts

• Principal investigator: Xin Zheng, Ph.D — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Xin Zheng, Ph.D

Conditions Diabetes; Hypertension; Hypercholesterolemia; dengzhanxixin capsule; platelet function; primary prevention