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Starting soon Phase 4

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

NCT05466968 · tracked via the Priya Life Science China tracker
Sponsor
Xiaolu Li
Phase
Phase 4
Started
2022-08-01
Last updated
2022-07-20

Condition(s) studied

Acute Myocardial Infarction

Investigational drug(s) / intervention(s)

Suxiao Jiuxin PillsThe placebo of Suxiao Jiuxin Pills

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

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

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • Changes of MMP-9 — Up to 30 minutes after administration
    MMP-9 measure by Elisa

Trial sites (1)

FacilityCityRegionStatus
Xiaolu Li Jinan China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05466968 on ClinicalTrials.gov ↗ ← All trials in China