Acute Coronary Syndrome
Conditions
Keywords
Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills
Brief summary
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.
Interventions
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline myocardial infarct size at 6 months | 3-5 days after PCI and 180±7 days | MI size measure by CMR |
| Change from baseline incidence of microvascular obstruction at 6 months | 3-5 days after PCI and 180±7 days | Incidence of Microvascular obstruction measure by CMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of ST segment in electrocardiogram | Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days | Change of ST segment in electrocardiogram |
| Change of CK-MB | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | CK-MB |
| Change of cTnI | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | cTnI |
| Change of NT-proBNP | Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days | NT-proBNP |
| Change of ejection fraction in echocardiography | Baseline, 3-5 days after PCI and 180±7 days | Ejection fraction measure by echocardiography |
| Change of 6 Minute Walk Test | 3-5 days after PCI, 30±7 days and 180±7 days | 6MWT is used to assess aerobic capacity and endurance |
| Change from baseline incidence of intramyocardial hemorrhagex at 6 months | 3-5 days after PCI and 180±7 days | Incidence of intramyocardial hemorrhagex measure by CMR |
| Incidence of MACCE | Through study completion, an average of 1 year | Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure |
| Incidence of complications of PCI | Up to 1 month | Cardiac shock, heart failure, mechanical complications and arrhythmia |
| Incidence of bleeding event | Up to 6 months | BARC Type 3 or 4 |
| Incidence of stent restenosis | 180±7 days | stent restenosis measure by CMR |
| Incidence of death event | Through study completion, an average of 1 year | Any death |
| Change of Seattle Angina Questionnaire (SAQ) | baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days | Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome. |
| Quantitative flow ratio | During the procedure | Index measure by QFR |
| Change from baseline incidence of area-at-risk at 6 months | 3-5 days after PCI and 180±7 days | Incidence of area-at-risk measure by CMR |
Contacts
Primary ContactMinzhou Zhang, Professor
Outcome results
None listed