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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suxiao Jiuxin Pills | Experimental | Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days |
|
| 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 180 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suxiao Jiuxin Pills | Drug | Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minzhou Zhang, Professor | Contact | +86-13924266368 | minzhouzhang@gzucm.edu.cn |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| The placebo of Suxiao Jiuxin Pills | Drug | The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste. |
|
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 |