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

Primary Purpose

Acute Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin Pills
Sponsored by
Xiaolu Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, suxiao jiuxin pills

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiaolu Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills

Arm Description

Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days

The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days

Outcomes

Primary Outcome Measures

Changes of MMP-9
MMP-9 measure by Elisa

Secondary Outcome Measures

Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".
TMP measure by CAG
Changes in the local morphology of vulnerable plaque
Proportion of lipid / necrotic core in plaque area by IVUS
Changes of PCSK9 in vulnerable plaque
PCSK9 measure by Elisa
Expression changes of local SMC-FC transformation indexes in vulnerable plaque
LOX-1 measure by Elisa
Expression changes of Local EC function index of vulnerable plaque
iNOS measure by Elisa
Expression changes of Local angiogenic factors in vulnerable plaque
VEGF measure by Elisa
Expression changes of indicators associated with vulnerable plaque rupture events
TNF-a measure by Elisa
Changes in coagulation related indicators in vulnerable plaque
Coagulation factor X measure by Elisa
The changes of inflammation related indicators
IL-6 by Omics research
Changes of remodeling indexes
LVEF measure by UCG
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

Full Information

First Posted
July 12, 2022
Last Updated
July 18, 2022
Sponsor
Xiaolu Li
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1. Study Identification

Unique Protocol Identification Number
NCT05466968
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaolu Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute myocardial infarction, suxiao jiuxin pills

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Drug: Suxiao Jiuxin Pills Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian). Drug: The placebo of Suxiao Jiuxin Pills The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suxiao Jiuxin Pills
Arm Type
Experimental
Arm Description
Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days
Arm Title
The placebo of Suxiao Jiuxin Pills
Arm Type
Placebo Comparator
Arm Description
The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 90 days
Intervention Type
Drug
Intervention Name(s)
Suxiao Jiuxin Pills
Other Intervention Name(s)
SJP group
Intervention Description
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
Intervention Type
Drug
Intervention Name(s)
The placebo of Suxiao Jiuxin Pills
Other Intervention Name(s)
Con group
Intervention Description
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
Primary Outcome Measure Information:
Title
Changes of MMP-9
Description
MMP-9 measure by Elisa
Time Frame
Up to 30 minutes after administration
Secondary Outcome Measure Information:
Title
Changes of TIMI myocardial perfusion (TMP) of "criminal vessel".
Description
TMP measure by CAG
Time Frame
Up to 30 minutes after administration
Title
Changes in the local morphology of vulnerable plaque
Description
Proportion of lipid / necrotic core in plaque area by IVUS
Time Frame
Up to 30 minutes after administration
Title
Changes of PCSK9 in vulnerable plaque
Description
PCSK9 measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
Expression changes of local SMC-FC transformation indexes in vulnerable plaque
Description
LOX-1 measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
Expression changes of Local EC function index of vulnerable plaque
Description
iNOS measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
Expression changes of Local angiogenic factors in vulnerable plaque
Description
VEGF measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
Expression changes of indicators associated with vulnerable plaque rupture events
Description
TNF-a measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
Changes in coagulation related indicators in vulnerable plaque
Description
Coagulation factor X measure by Elisa
Time Frame
Up to 30 minutes after administration
Title
The changes of inflammation related indicators
Description
IL-6 by Omics research
Time Frame
3 months after PCI
Title
Changes of remodeling indexes
Description
LVEF measure by UCG
Time Frame
3 months after PCI
Title
Changes in the incidence of MACE
Description
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
Time Frame
3 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nannan Li
Phone
15865266456
Email
1003023531@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolu Li
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiaolu Li
City
Jinan
ZIP/Postal Code
+86250001
Country
China

12. IPD Sharing Statement

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

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