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NCT Number: NCT05466968

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

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xiaolu Li

Jinan, +86250001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suxiao Jiuxin Pills

Drug

Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).

Other names: SJP group

The placebo of Suxiao Jiuxin Pills

Drug

The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

Other names: Con group

Primary outcomes

  1. Changes of MMP-9

    Time frame: Up to 30 minutes after administration

    MMP-9 measure by Elisa

Secondary outcomes

  1. Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".

    Time frame: Up to 30 minutes after administration

    TMP measure by CAG

  2. Changes in the local morphology of vulnerable plaque

    Time frame: Up to 30 minutes after administration

    Proportion of lipid / necrotic core in plaque area by IVUS

  3. Changes of PCSK9 in vulnerable plaque

    Time frame: Up to 30 minutes after administration

    PCSK9 measure by Elisa

  4. Expression changes of local SMC-FC transformation indexes in vulnerable plaque

    Time frame: Up to 30 minutes after administration

    LOX-1 measure by Elisa

  5. Expression changes of Local EC function index of vulnerable plaque

    Time frame: Up to 30 minutes after administration

    iNOS measure by Elisa

  6. Expression changes of Local angiogenic factors in vulnerable plaque

    Time frame: Up to 30 minutes after administration

    VEGF measure by Elisa

  7. Expression changes of indicators associated with vulnerable plaque rupture events

    Time frame: Up to 30 minutes after administration

    TNF-a measure by Elisa

  8. Changes in coagulation related indicators in vulnerable plaque

    Time frame: Up to 30 minutes after administration

    Coagulation factor X measure by Elisa

  9. The changes of inflammation related indicators

    Time frame: 3 months after PCI

    IL-6 by Omics research

  10. Changes of remodeling indexes

    Time frame: 3 months after PCI

    LVEF measure by UCG

  11. Changes in the incidence of MACE

    Time frame: 3 months after PCI

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nannan Li

CONTACT

[email protected]

15865266456

Sponsors and collaborators

Lead sponsor

Xiaolu Li

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jul 20, 2022
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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