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

NCT05459519 | Unknown DMC

• 1 other identifier: SFLX2022004
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes; Hypertension; Hypercholesterolemia

Keywords

dengzhanxixin capsule; platelet function; primary prevention

Outcome Measures

Primary Outcomes (1)

• Changes in rate of platelet aggregation

  inhibition of adenosine diphosphate (ADP)-induced platelet aggregation as measured by optical aggregometry at week 8.

  "Day 0", "Week 8"

Secondary Outcomes (9)

• Changes in rate of platelet aggregation

  "Day 0","Week 4","Week 8"

• Changes in blood pressure

  "Day 0","Week 4","Week 8"

• Changes in serum lipid profile

  "Day 0","Week 4","Week 8"

• Changes in coagulation profile

  "Day 0","Week 4","Week 8"

• Changes in fibrinogen

  "Day 0","Week 4","Week 8"

Study Arms (3)

Intervention group A

EXPERIMENTAL

Dengzhanxixin Capsules plus Placebo Capsules

Drug: Dengzhanxixin Capsule plus Placebo Capsule

Intervention group B

EXPERIMENTAL

Dengzhanxixin Capsules plus Placebo Capsules

Drug: Dengzhanxixin Capsule plus Placebo Capsule

Control group

PLACEBO COMPARATOR

Placebo Capsules

Drug: Placebo

Interventions

Dengzhanxixin Capsule plus Placebo Capsule DRUG

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

Intervention group A

Placebo DRUG

Placebo, 4 capsules each time, twice daily

Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The following three conditions must be met at the same time:
• Age \> 40 years, \< 70 years
• 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)
• Sign the informed consent

You may not qualify if:

• Those who meet any of the following conditions are not eligible:
• Diagnosed ASCVD, such as coronary heart disease, stroke and peripheral vascular disease
• Past history of heart failure
• History of symptomatic non-traumatic intracerebral hemorrhage at any time
• History of gastrointestinal bleeding within the past 3 months or history of major surgery within 30 days
• Need to use anticoagulation, antiplatelet or frequent use of non-steroidal anti-inflammatory drugs
• Have used Dengzhanxixin or preparations containing Dengzhanxixin in the past 1 month
• Have clear adverse reactions to Dengzhanxixin in the past
• Active liver disease, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 2 times the upper limit of normal (ULN)
• Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/(min×1.73m2)
• Pregnant or planning to become pregnant, or breastfeeding
• Malignant tumors, or other serious diseases with an expected survival period of less than 1 year
• Mental disorders or communication disorders, cognitive dysfunction, or other serious diseases that may affect participation in the study
• Have participated in or are participating in other clinical trials in the past 1 month
• Known poor adherence to study follow-up or study medication

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, ShenZhen, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Xin Zheng, Ph.D

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Jing Li, Ph.D

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zheng, Ph.D

CONTACT

xin.zheng@fwoxford.org

Xiaofang Yan, M.S

CONTACT

xiaofang.yan@fwoxford.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 15, 2022
• Study Start: July 20, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)