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

NCT05466968 | Not Yet Recruiting Phase 4

• 1 other identifier: YXLL-KY-2022(030)
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarction; suxiao jiuxin pills

Outcome Measures

Primary Outcomes (1)

• Changes of MMP-9

  MMP-9 measure by Elisa

  Up to 30 minutes after administration

Secondary Outcomes (11)

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

  Up to 30 minutes after administration

• Changes in the local morphology of vulnerable plaque

  Up to 30 minutes after administration

• Changes of PCSK9 in vulnerable plaque

  Up to 30 minutes after administration

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

  Up to 30 minutes after administration

• Expression changes of Local EC function index of vulnerable plaque

  Up to 30 minutes after administration

Study Arms (2)

Suxiao Jiuxin Pills

EXPERIMENTAL

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

Drug: Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills

PLACEBO COMPARATOR

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

Interventions

Suxiao Jiuxin Pills DRUG

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

Also known as: SJP group

Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills DRUG

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

Also known as: Con group

The placebo of Suxiao Jiuxin Pills

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaolu Li: lead

Study Sites (1)

Xiaolu Li

Jinan, +86250001, China

Location

Study Officials

• Xiaolu Li

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nannan Li

CONTACT

15865266456; 1003023531@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)