Effects of Dengzhanxixin Capsule on Platelet Function in Individuals at High Risk for Cardiovascular Disease

NCT ID: NCT05459519

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes; Hypertension; Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group A

Dengzhanxixin Capsules plus Placebo Capsules

Group Type: EXPERIMENTAL

Dengzhanxixin Capsule plus Placebo Capsule

Intervention Type: DRUG

Dengzhanxixin Capsule, 0.54g (3 capsules) each time, twice daily; placebo, 1 capsule, twice daily

Intervention group B

Dengzhanxixin Capsules plus Placebo Capsules

Group Type: EXPERIMENTAL

Dengzhanxixin Capsule plus Placebo Capsule

Intervention Type: DRUG

Dengzhanxixin Capsule, 0.72g (4 capsules) each time, once daily; placebo, 4 capsules, once daily

Control group

Placebo Capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 4 capsules each time, twice daily

Interventions

Dengzhanxixin Capsule plus Placebo Capsule

Dengzhanxixin Capsule, 0.54g (3 capsules) each time, twice daily; placebo, 1 capsule, twice daily

Intervention Type: DRUG

Placebo

Placebo, 4 capsules each time, twice daily

Intervention Type: DRUG

Dengzhanxixin Capsule plus Placebo Capsule

Dengzhanxixin Capsule, 0.72g (4 capsules) each time, once daily; placebo, 4 capsules, once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Zheng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Jing Li, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, ShenZhen, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Zheng, Ph.D

Role: CONTACT

xin.zheng@fwoxford.org

Xiaofang Yan, M.S

Role: CONTACT

xiaofang.yan@fwoxford.org

Facility Contacts

Xin Zheng

Role: primary

Other Identifiers

SFLX2022004

Identifier Type: -

Identifier Source: org_study_id