Clinical trial NCT04814121: Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome
Official title: Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Microvascular obstruction
Acute Coronary Syndrome
Percutaneous coronary intervention
Suxiao Jiuxin Pills
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline myocardial infarct size at 6 months
timeFrame: 3-5 days after PCI and 180±7 days
measure: Change from baseline incidence of microvascular obstruction at 6 months
timeFrame: 3-5 days after PCI and 180±7 days
Secondary outcomes:
measure: Change from baseline incidence of intramyocardial hemorrhagex at 6 months
timeFrame: 3-5 days after PCI and 180±7 days
measure: Change from baseline incidence of area-at-risk at 6 months
timeFrame: 3-5 days after PCI and 180±7 days
measure: Change of ST segment in electrocardiogram
timeFrame: Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
measure: Change of CK-MB
timeFrame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
measure: Change of cTnI
timeFrame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
measure: Change of NT-proBNP
timeFrame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
measure: Change of ejection fraction in echocardiography
timeFrame: Baseline, 3-5 days after PCI and 180±7 days
measure: Change of 6 Minute Walk Test
timeFrame: 3-5 days after PCI, 30±7 days and 180±7 days
measure: Quantitative flow ratio
timeFrame: During the procedure
measure: Incidence of MACCE
timeFrame: Through study completion, an average of 1 year
measure: Incidence of complications of PCI
timeFrame: Up to 1 month
measure: Incidence of bleeding event
timeFrame: Up to 6 months
measure: Incidence of stent restenosis
timeFrame: 180±7 days
measure: Incidence of death event
timeFrame: Through study completion, an average of 1 year
measure: Change of Seattle Angina Questionnaire (SAQ)
timeFrame: baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days
Other outcomes:
Locations:
Study officials:
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