Intervention of Suxiao Jiuxin Pill on Instability of Vulnerable Plaque in Acute Myocardial Infarction

Study Overview
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Brief Summary
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The incidence of cardiovascular disease is still high in China under the condition of non-standard treatment of Western medicine. Acute coronary plaque rupture and thrombosis is an extreme manifestation of instability of vulnerable plaque, which is the result of the joint action of multiple factors. The intervention of unstable plaque reversal from multiple factors is inherently reasonable. Compared with the treatment of thrombosis and unstable plaque in western medicine, quick acting Jiuxin Pill can not only calm and relieve pain for pain and other symptoms, but also regulate immune inflammation and metabolic disorder, improve microcirculation and anti myocardial ischemia. In order to evaluate the efficacy, safety and modern scientific basis of Suxiao Jiuxin Pill in acute myocardial infarction (AMI), the investigators designed this study.

Detailed Description
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Under the condition of standardized western medicine treatment, the incidence and disability rate of cardiovascular disease in China is still high. There has been a wealth of clinical practice in the treatment of acute myocardial infarction with traditional Chinese medicine, and clinical evidence-based exploration is an inevitable trend. Suxiao Jiuxin Pill is a classic old medicine, but large-scale randomized controlled trial are still needed to consolidate the efficacy, safety and modern scientific basis in acute myocardial infarction (AMI). This pilot single center standardization research is the most basic support and exploration. This project can enhance the influence of Suxiao Jiuxin pills in the context of modern science, which will help the products to be more widely used in Chinese and western hospitals, benefit more patients, reduce the health economics cost of patients with acute ischemia of coronary heart disease at home and abroad, and reduce the social burden. From the perspective of local vulnerable plaque instability and vulnerable patients systemic inflammation outbreak driving plaque rupture, this study aims to clarify the effect of Suxiao Jiuxin Pill on thrombotic lesions, systemic and clinical short-term prognosis in patients with acute ST segment elevation myocardial infarction (STEMI) from multi-target and multi-component. This study provides evidence for the mechanism of Suxiao Jiuxin Pill in the comprehensive prevention and treatment of pathophysiological disorders in STEMI patients.

Official Title
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Clinical Trial of Suxiao Jiuxin Pill on the Instability of Vulnerable Plaque With Integrated Traditional Chinese Medicine and Western Medicine in Acute ST-segment Elevation Myocardial Infarction(STEMI) Patient

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Suxiao Jiuxin Pills
* Drug: The placebo of Suxiao Jiuxin Pills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-75; Meet the diagnosis of AMI global definition version 4，admit from emergency department; Prepare for emergency coronary angiography and PCI reperfusion therapy; Volunteer to participate in this study and have signed an informed consent form. Exclusion Criteria: AMI with cardiogenic shock (Killip grade ≥ grade III) and no response to vasopressin; AMI complicated with severe arrhythmia (persistent ventricular tachycardia, ventricular fibrillation); AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, intracardiac thrombus, ventricular free wall rupture); Severe systemic diseases (immune system diseases, sepsis and other serious infections, blood system diseases, massive hemorrhage caused by anticoagulation and antithrombotic therapy, and severe organ failure (such as ALT ≥ 3 ULN, cr> 134 μ Mol/l (2mg/dl) or egfr<45ml/min/1.73m2); History of cerebral hemorrhage and cerebral aneurysm within 3 months; Mental patients; Malignant tumor or other pathophysiological condition with expected survival less than 1 year; Those who are allergic to the drug components of this study; Pregnant or lactating women; Patients who have participated in clinical trials of other drugs within 3 months before enrollment or took other Chinese patent medicines with similar effects within the first three months of enrollment; Other diseases with clinical significance that may cause serious danger to patients. In TCM syndrome types, Qi deficiency, Yang deficiency and other deficiency syndrome types, and cold congealing heart pulse syndrome types in positive syndrome types.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental: Suxiao Jiuxin Pills Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days Placebo Comparator: The placebo of Suxiao Jiuxin Pills The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suxiao Jiuxin Pills<br>Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days | Drug: Suxiao Jiuxin Pills<br>* Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).<br>* Other names: SJP group;|
| Placebo Comparator: The placebo of Suxiao Jiuxin Pills<br>The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days | Drug: The placebo of Suxiao Jiuxin Pills<br>* The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.<br>* Other names: Con group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of MMP-9 | MMP-9 measure by Elisa | Up to 30 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of TIMI myocardial perfusion (TMP) of criminal vessel. | TMP measure by CAG | Up to 30 minutes after administration | 
| Changes in the local morphology of vulnerable plaque | Proportion of lipid / necrotic core in plaque area by IVUS | Up to 30 minutes after administration | 
| Changes of PCSK9 in vulnerable plaque | PCSK9 measure by Elisa | Up to 30 minutes after administration | 
| Expression changes of local SMC-FC transformation indexes in vulnerable plaque | LOX-1 measure by Elisa | Up to 30 minutes after administration | 
| Expression changes of Local EC function index of vulnerable plaque | iNOS measure by Elisa | Up to 30 minutes after administration | 
| Expression changes of Local angiogenic factors in vulnerable plaque | VEGF measure by Elisa | Up to 30 minutes after administration | 
| Expression changes of indicators associated with vulnerable plaque rupture events | TNF-a measure by Elisa | Up to 30 minutes after administration | 
| Changes in coagulation related indicators in vulnerable plaque | Coagulation factor X measure by Elisa | Up to 30 minutes after administration | 
| The changes of inflammation related indicators | IL-6 by Omics research | 3 months after PCI | 
| Changes of remodeling indexes | LVEF measure by UCG | 3 months after PCI | 
| Changes in the incidence of MACE | Recurrent unstable angina pectoris, non fatal myocardial infarction, cardiogenic death, revascularization (pci+cabg), stroke, heart failure requiring hospitalization and all-cause death measure by data statistics | 3 months after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, suxiao jiuxin pills