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DiabetesFUTURENCT05459519

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

A study of Diabetes and Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Hypertension, Hypercholesterolemia
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
1 siteChina
Study dates
20 Jul 2022to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The following three conditions must be met at the same time:
  • Age > 40 years, < 70 years
  • Meet any of the following conditions:
  • Diabetes
  • LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L
  • 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)
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Xin Zheng, Ph.D contact

xin.zheng@fwoxford.org

Xiaofang Yan, M.S contact

xiaofang.yan@fwoxford.org

China1 site, 1 recruiting

  • Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, ShenZhen

    Xin Zheng

    Recruiting

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Dengzhanxixin Capsule plus Placebo Capsule, Placebo
Keywords
dengzhanxixin capsule; platelet function; primary prevention
Medical subject headings
Diabetes Mellitus, Hypertension, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dengzhanxixin Capsule plus Placebo CapsuleDrug

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

  • PlaceboDrug

    Placebo, 4 capsules each time, twice daily

  • Dengzhanxixin Capsule plus Placebo CapsuleDrug

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

Study groups in NCT05459519
Study groupRoleWhat they receive
Intervention group AExperimentalDengzhanxixin Capsules plus Placebo Capsules
Receives: Drug: Dengzhanxixin Capsule plus Placebo Capsule
Intervention group BExperimentalDengzhanxixin Capsules plus Placebo Capsules
Receives: Drug: Dengzhanxixin Capsule plus Placebo Capsule
Control groupPlacebo comparatorPlacebo Capsules
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in rate of platelet aggregation

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

    Measured: "Day 0", "Week 8"

Secondary outcomes (9)

  1. Changes in rate of platelet aggregation

    1. inhibition of arachidonic acid (AA) and collagen (COLL) -induced platelet aggregation measured by optical aggregometry at week 8.
    2. inhibition of ADP, AA and COLL -induced platelet aggregation measured by optical aggregometry at week 4.
    3. At 4 weeks and 8 weeks from baseline, compare the differences of platelet P2Y12 response units (PRU) and aspirin response units (ARU)
    4. At 4 weeks and 8 weeks of treatment, compare the differences of P-selectin.

    Measured: "Day 0","Week 4","Week 8"

  2. 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

    Measured: "Day 0","Week 4","Week 8"

  3. 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

    Measured: "Day 0","Week 4","Week 8"

  4. 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

    Measured: "Day 0","Week 4","Week 8"

  5. Changes in fibrinogen

    changes in fibrinogen (g/L) at 4 and 8 weeks of treatment compared with baseline

    Measured: "Day 0","Week 4","Week 8"

  6. Changes in hs-CRP

    changes in high-sensitivity C-reactive protein (mg/dL) at 4 and 8 weeks of treatment compared with baseline

    Measured: "Day 0","Week 4","Week 8"

  7. Changes in IL-6

    changes in interleukin-6 (pg/mL) at 4 and 8 weeks of treatment compared with baseline

    Measured: "Day 0","Week 4","Week 8"

  8. Changes in HbA1c(%)

    Changes in HbA1c at 8 weeks of treatment compared with baseline

    Measured: "Day 0", "Week 8"

  9. Number of Participants with safety endpoint

    1. Liver-relate indicators:
    2. ALT ≥ 5 times ULN, or
    3. ALT ≥ 3 times ULN + bilirubin ≥ 2 times ULN (3) Kidney-related indicators:
    4. 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

    Measured: through study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start20 Jul 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05459519
Sponsor's protocol ID
SFLX2022004
Acronym
FUTURE
Status last verified
Jul 2023
First submitted
26 Jun 2022
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Diabetes and Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Zheng, Ph.D (xin.zheng@fwoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in rate of platelet aggregation (time frame: "Day 0", "Week 8"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05459519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.

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