Xiaolu Li
Jinan, +86250001, China
NCT Number: NCT05466968
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.
Trial opening soon.
Get Notified30 year–75 year
All sexes
Interventional
Phase 4
Jinan, +86250001, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
Other names: SJP group
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
Other names: Con group
Time frame: Up to 30 minutes after administration
MMP-9 measure by Elisa
Time frame: Up to 30 minutes after administration
TMP measure by CAG
Time frame: Up to 30 minutes after administration
Proportion of lipid / necrotic core in plaque area by IVUS
Time frame: Up to 30 minutes after administration
PCSK9 measure by Elisa
Time frame: Up to 30 minutes after administration
LOX-1 measure by Elisa
Time frame: Up to 30 minutes after administration
iNOS measure by Elisa
Time frame: Up to 30 minutes after administration
VEGF measure by Elisa
Time frame: Up to 30 minutes after administration
TNF-a measure by Elisa
Time frame: Up to 30 minutes after administration
Coagulation factor X measure by Elisa
Time frame: 3 months after PCI
IL-6 by Omics research
Time frame: 3 months after PCI
LVEF measure by UCG
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
Contact information is provided by the study sponsor or research team.
Xiaolu Li
Other
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
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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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