Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.

Official Title
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Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Suxiao Jiuxin Pills
* Drug: The placebo of Suxiao Jiuxin Pills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnosis of AMI, prepare for PCI reperfusion therapy; Between the ages of 18-75; Volunteer to participate in this study and have signed an informed consent form; Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation. Exclusion Criteria: Not suitable for coronary intervention; With unstable hemodynamics; Platelet count<100×109; Suspected aortic dissection or acute pulmonary embolism; With mechanical complications; With uncontrolled acute left heart failure and pulmonary edema; With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction; Meantain anticoagulants (such as warfarin or new anticoagulants); Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl) or eGFR<45ml/min/1.73m2); CTO, stent stenosis, or severe left main disease; History of coronary artery bypass graft surgery; Other pathophysiological conditions whose expected survival period is less than 1 year; Allergic history to Suxiao Jiuxin Pills; Pregnant or lactating women; Participating in other clinical studies; With other diseases that are not suitable for participating in clinical research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suxiao Jiuxin Pills<br>Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days | Drug: Suxiao Jiuxin Pills<br>* Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).<br>|
| Placebo Comparator: The placebo of Suxiao Jiuxin Pills<br>The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days | Drug: The placebo of Suxiao Jiuxin Pills<br>* The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline myocardial infarct size at 6 months | MI size measure by CMR | 3-5 days after PCI and 180±7 days | 
| Change from baseline incidence of microvascular obstruction at 6 months | Incidence of Microvascular obstruction measure by CMR | 3-5 days after PCI and 180±7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline incidence of intramyocardial hemorrhagex at 6 months | Incidence of intramyocardial hemorrhagex measure by CMR | 3-5 days after PCI and 180±7 days | 
| Change from baseline incidence of area-at-risk at 6 months | Incidence of area-at-risk measure by CMR | 3-5 days after PCI and 180±7 days | 
| Change of ST segment in electrocardiogram | Change of ST segment in electrocardiogram | Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days | 
| Change of CK-MB | CK-MB | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | 
| Change of cTnI | cTnI | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | 
| Change of NT-proBNP | NT-proBNP | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | 
| Change of ejection fraction in echocardiography | Ejection fraction measure by echocardiography | Baseline, 3-5 days after PCI and 180±7 days | 
| Change of 6 Minute Walk Test | 6MWT is used to assess aerobic capacity and endurance | 3-5 days after PCI, 30±7 days and 180±7 days | 
| Quantitative flow ratio | Index measure by QFR | During the procedure | 
| Incidence of MACCE | Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure | Through study completion, an average of 1 year | 
| Incidence of complications of PCI | Cardiac shock, heart failure, mechanical complications and arrhythmia | Up to 1 month | 
| Incidence of bleeding event | BARC Type 3 or 4 | Up to 6 months | 
| Incidence of stent restenosis | stent restenosis measure by CMR | 180±7 days | 
| Incidence of death event | Any death | Through study completion, an average of 1 year | 
| Change of Seattle Angina Questionnaire (SAQ) | Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome. | baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills