Clinical trial NCT05459519: Effects of Dengzhanxixin Capsule on Platelet Function in Individuals at High Risk for Cardiovascular Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Hypertension
Hypercholesterolemia
Keywords: dengzhanxixin capsule; platelet function; primary prevention
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2022-07-15
Enrollment: 165
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of cardiovascular death, and one out of every ten people aged 35-75 in China is at high risk for ASCVD. Platelet activation is an important mechanism for the development of atherosclerosis. Antiplatelet therapy is important in preventing ASCVD.

Dengzhanxixin capsule is an over-the-counter Chinese traditional medicine; currently, it is mainly used for the adjuvant treatment of ischemic stroke and coronary heart disease. A study of 3143 patients with ischemic stroke found that the addition of Dengzhanshengmai capsules to the standard treatment could further reduce the risk of recurrent stroke and was well tolerated without increased risk of bleeding. Animal experiments also observed that Dengzhanxixin capsules had a clear antiplatelet effect. However, the antiplatelet function of Dengzhanxixin capsules in humans is still unclear. In addition, Dengzhanxixin capsules also have potential anti-inflammatory, lipid-lowering, anticoagulant, and antihypertensive effects.

The main objective of this study is to evaluate the antiplatelet efficacy and safety of Dengzhanxixin capsules in individuals at high-risk for ASCVD. The plan of the study is to recruit 165 subjects and the follow up is to be 10 weeks. This study has been approved by the Ethics Committee of Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen.

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

Primary outcomes:
measure: Changes in rate of platelet aggregation
timeFrame: "Day 0", "Week 8"
Secondary outcomes:
measure: Changes in rate of platelet aggregation
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in blood pressure
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in serum lipid profile
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in coagulation profile
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in fibrinogen
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in hs-CRP
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in IL-6
timeFrame: "Day 0","Week 4","Week 8"
measure: Changes in HbA1c(%)
timeFrame: "Day 0", "Week 8"
measure: Number of Participants with safety endpoint
timeFrame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: ShenZhen
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen
state: ShenZhen
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xin Zheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jing Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: