ACS
Conditions
Interventions
Experimental group:Conventional Western medical treatment (oral medication and standard PCI) combined with Placebo (Xuesaitong soft capsule Placebo), 0.33g per capsule, 2 capsules per dose, twice dail
Positive control group:Conventional Western medical treatment (oral medication and standard PCI) combined with Xuesaitong soft capsule 0.33g per capsule 2 capsules per dose twice daily for 12 weeks wi
Open label group:Conventional Western medical treatment (oral medication and standard PCI) combined with Xuesaitong soft capsule 0.33g per capsule 2 capsules per dose twice daily for 1 month with no f
Sponsors
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Patients diagnosed with acute ST-segment elevation myocardial infarction acute non-ST-segment elevation myocardial infarction or unstable angina according to Western medical standards. (2)Patients diagnosed with blood stasis according to Western medical standards. (3)Within 4 weeks post-PCI. (4)Aged between 18 and 80 years both male and female. (5)Voluntarily participating in the clinical trial having signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Uncontrolled hypertension after medication (systolic BP >180mmHg or diastolic BP > 110mmHg). (2)Increased bleeding risk: history of hemorrhagic stroke; intracranial aneurysm; major trauma or surgery within the past month (including Exclusion Criteria bypass surgery); active bleeding disorders. (3)History of gastrointestinal ulcers or significant gastrointestinal bleeding. (4)Severe organic heart disease such as LVEF < 35% or NYHA/Killip heart function grade IV. (5)History of malignant arrhythmias within the past year (arrhythmias affecting hemodynamics requiring medication or electrical cardioversion or requiring CPR) congenital heart disease or malignant tumors. (6)Severe liver or kidney dysfunction: ALT or AST = 3×ULN TBIL= 2×ULN or creatinine clearance < 30ml/min. (7)Pregnant or lactating women. (8)Recent blood donation or significant blood loss within the past 3 months (=400ml). (9)History of alcohol abuse (=28 standard units/week for males =21 standard units/week for females) or frequent alcohol consumption in the past 6 months (=14 standard units/week). (10)History of drug abuse or dependence within the past year. (11)Participation in other clinical trials and taking trial drugs within the past 3 months. (12)Allergy or intolerance to aspirin or P2Y12 receptor inhibitors. (13)Allergy to any components of the trial drug. (14)Other conditions deemed inappropriate for participation by the nvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary composite endpoint event (cardiac death nonfatal myocardial infarction emergency revascularization); | — |
Secondary
| Measure | Time frame |
|---|---|
| Each component of the primary composite endpoint event, all-cause mortality and BARC hemorrhage (grades 2 /3/ 5); | — |
Countries
China
Contacts
Public ContactSHI Dazhuo
Xiyuan Hospital of China Academy of Traditional Chinese Medicine
Outcome results
None listed