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

Primary Purpose

Diabetes, Hypertension, Hypercholesterolemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dengzhanxixin Capsule plus Placebo Capsule
Placebo
Dengzhanxixin Capsule plus Placebo Capsule
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring dengzhanxixin capsule; platelet function; primary prevention

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences, ShenzhenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Intervention group A

Intervention group B

Control group

Arm Description

Dengzhanxixin Capsules plus Placebo Capsules

Dengzhanxixin Capsules plus Placebo Capsules

Placebo Capsules

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in rate of platelet aggregation
inhibition of arachidonic acid (AA) and collagen (COLL) -induced platelet aggregation measured by optical aggregometry at week 8. inhibition of ADP, AA and COLL -induced platelet aggregation measured by optical aggregometry at week 4. At 4 weeks and 8 weeks from baseline, compare the differences of platelet P2Y12 response units (PRU) and aspirin response units (ARU) At 4 weeks and 8 weeks of treatment, compare the differences of P-selectin.
Changes in blood pressure
Changes in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 4 and 8 weeks of treatment compared with baseline
Changes in serum lipid profile
changes in total cholesterol (mg/dL) , low-density lipoprotein cholesterol ester (mg/dL) , high-density lipoprotein cholesterol ester (mg/dL) , triglyceride (mg/dL) and lipoprotein(a) (mg/dL) at 4 and 8 weeks of treatment compared with baseline
Changes in coagulation profile
changes in prothrombin time (s), activated partial thromboplastin time (s), and thrombin time (s) at 4 and 8 weeks of treatment compared with baseline
Changes in fibrinogen
changes in fibrinogen (g/L) at 4 and 8 weeks of treatment compared with baseline
Changes in hs-CRP
changes in high-sensitivity C-reactive protein (mg/dL) at 4 and 8 weeks of treatment compared with baseline
Changes in IL-6
changes in interleukin-6 (pg/mL) at 4 and 8 weeks of treatment compared with baseline
Changes in HbA1c(%)
Changes in HbA1c at 8 weeks of treatment compared with baseline
Number of Participants with safety endpoint
2) Liver-relate indicators: ALT ≥ 5 times ULN, or ALT ≥ 3 times ULN + bilirubin ≥ 2 times ULN (3) Kidney-related indicators: a. Serum creatinine increased by ≥50% from baseline, or b. Change in eGFR from baseline (4) Serious adverse events (5) Other adverse events related to the study drug (6) Drug discontinuation due to any reason

Full Information

First Posted
June 26, 2022
Last Updated
July 23, 2023
Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Fuwai Hospital, Chinese Academy of Medial Sciences, Shenzhen, Shenzhen
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1. Study Identification

Unique Protocol Identification Number
NCT05459519
Brief Title
Effects of Dengzhanxixin Capsule on Platelet Function in Individuals at High Risk for Cardiovascular Disease
Acronym
FUTURE
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Fuwai Hospital, Chinese Academy of Medial Sciences, Shenzhen, Shenzhen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Hypercholesterolemia
Keywords
dengzhanxixin capsule; platelet function; primary prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group A
Arm Type
Experimental
Arm Description
Dengzhanxixin Capsules plus Placebo Capsules
Arm Title
Intervention group B
Arm Type
Experimental
Arm Description
Dengzhanxixin Capsules plus Placebo Capsules
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo Capsules
Intervention Type
Drug
Intervention Name(s)
Dengzhanxixin Capsule plus Placebo Capsule
Intervention Description
Dengzhanxixin Capsule, 0.54g (3 capsules) each time, twice daily; placebo, 1 capsule, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 4 capsules each time, twice daily
Intervention Type
Drug
Intervention Name(s)
Dengzhanxixin Capsule plus Placebo Capsule
Intervention Description
Dengzhanxixin Capsule, 0.72g (4 capsules) each time, once daily; placebo, 4 capsules, once daily
Primary Outcome Measure Information:
Title
Changes in rate of platelet aggregation
Description
inhibition of adenosine diphosphate (ADP)-induced platelet aggregation as measured by optical aggregometry at week 8.
Time Frame
"Day 0", "Week 8"
Secondary Outcome Measure Information:
Title
Changes in rate of platelet aggregation
Description
inhibition of arachidonic acid (AA) and collagen (COLL) -induced platelet aggregation measured by optical aggregometry at week 8. inhibition of ADP, AA and COLL -induced platelet aggregation measured by optical aggregometry at week 4. At 4 weeks and 8 weeks from baseline, compare the differences of platelet P2Y12 response units (PRU) and aspirin response units (ARU) At 4 weeks and 8 weeks of treatment, compare the differences of P-selectin.
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in blood pressure
Description
Changes in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in serum lipid profile
Description
changes in total cholesterol (mg/dL) , low-density lipoprotein cholesterol ester (mg/dL) , high-density lipoprotein cholesterol ester (mg/dL) , triglyceride (mg/dL) and lipoprotein(a) (mg/dL) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in coagulation profile
Description
changes in prothrombin time (s), activated partial thromboplastin time (s), and thrombin time (s) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in fibrinogen
Description
changes in fibrinogen (g/L) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in hs-CRP
Description
changes in high-sensitivity C-reactive protein (mg/dL) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in IL-6
Description
changes in interleukin-6 (pg/mL) at 4 and 8 weeks of treatment compared with baseline
Time Frame
"Day 0","Week 4","Week 8"
Title
Changes in HbA1c(%)
Description
Changes in HbA1c at 8 weeks of treatment compared with baseline
Time Frame
"Day 0", "Week 8"
Title
Number of Participants with safety endpoint
Description
2) Liver-relate indicators: ALT ≥ 5 times ULN, or ALT ≥ 3 times ULN + bilirubin ≥ 2 times ULN (3) Kidney-related indicators: a. Serum creatinine increased by ≥50% from baseline, or b. Change in eGFR from baseline (4) Serious adverse events (5) Other adverse events related to the study drug (6) Drug discontinuation due to any reason
Time Frame
through study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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: Failure to complete the lead-in treatment The occurrence of placebo-related adverse reactions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zheng, Ph.D
Email
xin.zheng@fwoxford.org
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofang Yan, M.S
Email
xiaofang.yan@fwoxford.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Zheng, Ph.D
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Li, Ph.D
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen
City
ShenZhen
State/Province
ShenZhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zheng

12. IPD Sharing Statement

Plan to Share IPD
No

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

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