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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Suxiao Jiuxin Pills; Drug: The placebo of Suxiao Jiuxin Pills

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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nannan Li; Phone Number: 15865266456; Email: 1003023531@qq.com

Study Locations

• China
  • Jinan, China, +86250001
    • Xiaolu Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiaolu Li
• Investigators: Principal Investigator: Xiaolu Li, The First Affiliated Hospital Of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): June 1, 2027

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: acute myocardial infarction; suxiao jiuxin pills
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: YXLL-KY-2022(030)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No