Acute coronary syndrome
Conditions
Interventions
Esperimental group:Standardized treatment of acute coronary syndrome + Tongxinluo capsule 4 capsules / time, 3 times / day, oral
Control group:Standardized treatment of acute coronary syndrome + Tongxinluo capsule placebo 4 capsules / time, 3 times / day, oral
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-80 years; 2. Meet with NSTE-ACS diagnostic criteria; Coronary angiography confirmed the presence of stent-free stenosis, and the defined scope met one of the following criteria: (1) Coronary artery stenosis with diameter less than 70% does not require stent implantation, which could be used as OCT observation target. (2) Coronary artery stenosis with diameter more than 70%, stent implantation and other vessels without interventional treatment, which could be selected as the target of OCT observation. (3) Coronary artery stenosis with diameter more than 70%, stent implantation during operation, and stenosis without interventional treatment in other parts of the same vessel, which is more than 5 mm away from the edge of the stent, could be used as the target of OCT observation. Note: OCT screening criteria for enrolled coronary artery plaques: fiber cap thickness90 °. 3. The imaging results showed AS lesions in situ (not in stent or CABG). 4. The informed consent was signed by the patients themselves or their legal representatives before the study began.
Exclusion criteria
Exclusion criteria: 1. Coronary angiography showed left main artery and/or right coronary artery opening lesions; 2. A history of myocardial infarction or stroke within one month. 3. Type 1 diabetes; familial hypercholesterolemia; patients requiring warfarin anticoagulation therapy; 4. Takayasu arteritis; 5. Pregnancy or lactation, or having fertility intention within one year, or failing to take effective contraceptive measures during childbearing age; 6. Liver dysfunction (3.0 times higher than the upper limit of normal value) and renal dysfunction (creatinine over 2 mg/dl); 7. Severe chronic obstructive pulmonary disease (COPD) or respiratory failure; a history of gastrointestinal, respiratory or other organ bleeding within the last month; severe infections; severe weakness, such as cachexia; malignant tumors; neuropsychiatric disorders; 8. Other pathophysiological conditions with a life expectancy of less than 1 year; 9. Allergic to the drug ingredients in this study; participating in other clinical studies; 10. With other diseases that are not suitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thickness of fibrous cap of target vessel plaque; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of fibrous plaque, calcified plaque, ruptured plaque and thrombus in patients NSTE-ACS treated with Tongxinluo Capsule after 1 year; to analyze the changes of lipid angle and length of plaque.;To evaluate the incidence of one-year composite endpoint events (including all-cause death, sudden cardiac death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for angina pectoris or heart failure, PCI or CABG for ACS) in patients with NSTE-ACS.;Severity of angina pectoris (Canadian Cardiovascular Society angina classification);Seattle Angina Questionnaire(SAQ);Levels of inflammatory factors (IL-1beta, IL-18, TNF-alpha);Clinical mechanism indicators of some research centers: changes of intestinal flora; | — |
Countries
China
Contacts
Public ContactPeili Bu
Qilu Hospital of Shandong University
Outcome results
None listed