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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
165
Dengzhanxixin Capsule, 0.54g (3 capsules) each time, twice daily; placebo, 1 capsule, twice daily
Placebo, 4 capsules each time, twice daily
Dengzhanxixin Capsule, 0.72g (4 capsules) each time, once daily; placebo, 4 capsules, once daily
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, ShenZhen, China
RECRUITINGChanges in rate of platelet aggregation
inhibition of adenosine diphosphate (ADP)-induced platelet aggregation as measured by optical aggregometry at week 8.
Time frame: "Day 0", "Week 8"
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.
Time frame: "Day 0","Week 4","Week 8"
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
Time frame: "Day 0","Week 4","Week 8"
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
Time frame: "Day 0","Week 4","Week 8"
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
Time frame: "Day 0","Week 4","Week 8"
Changes in fibrinogen
changes in fibrinogen (g/L) at 4 and 8 weeks of treatment compared with baseline
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Time frame: "Day 0","Week 4","Week 8"
Changes in hs-CRP
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"
Changes in IL-6
changes in interleukin-6 (pg/mL) at 4 and 8 weeks of treatment compared with baseline
Time frame: "Day 0","Week 4","Week 8"
Changes in HbA1c(%)
Changes in HbA1c at 8 weeks of treatment compared with baseline
Time frame: "Day 0", "Week 8"
Number of Participants with safety endpoint
2\) Liver-relate indicators: 1. ALT ≥ 5 times ULN, or 2. 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