Clinical trial NCT05466968: Intervention of Suxiao Jiuxin Pill on Instability of Vulnerable Plaque in Acute Myocardial Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
suxiao jiuxin pills
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 116
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18-75;
2. Meet the diagnosis of AMI global definition version 4，admit from emergency department;
3. Prepare for emergency coronary angiography and PCI reperfusion therapy;
4. Volunteer to participate in this study and have signed an informed consent form.

Exclusion Criteria:

1. AMI with cardiogenic shock (Killip grade ≥ grade III) and no response to vasopressin;
2. AMI complicated with severe arrhythmia (persistent ventricular tachycardia, ventricular fibrillation);
3. AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, intracardiac thrombus, ventricular free wall rupture);
4. 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);
5. History of cerebral hemorrhage and cerebral aneurysm within 3 months;
6. Mental patients;
7. Malignant tumor or other pathophysiological condition with expected survival less than 1 year;
8. Those who are allergic to the drug components of this study;
9. Pregnant or lactating women;
10. 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;
11. Other diseases with clinical significance that may cause serious danger to patients.
12. In TCM syndrome types, Qi deficiency, Yang deficiency and other deficiency syndrome types, and cold congealing heart pulse syndrome types in positive syndrome types.

Primary outcomes:
measure: Changes of MMP-9
timeFrame: Up to 30 minutes after administration
Secondary outcomes:
measure: Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".
timeFrame: Up to 30 minutes after administration
measure: Changes in the local morphology of vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: Changes of PCSK9 in vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: Expression changes of local SMC-FC transformation indexes in vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: Expression changes of Local EC function index of vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: Expression changes of Local angiogenic factors in vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: Expression changes of indicators associated with vulnerable plaque rupture events
timeFrame: Up to 30 minutes after administration
measure: Changes in coagulation related indicators in vulnerable plaque
timeFrame: Up to 30 minutes after administration
measure: The changes of inflammation related indicators
timeFrame: 3 months after PCI
measure: Changes of remodeling indexes
timeFrame: 3 months after PCI
measure: Changes in the incidence of MACE
timeFrame: 3 months after PCI
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xiaolu Li
Study officials:
affiliation: Shandong First Medical University
name: Xiaolu Li
role: PRINCIPAL_INVESTIGATOR
References: