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

Guangzhou University of Traditional Chinese Medicine198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

198

Conditions

Acute Coronary Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline myocardial infarct size at 6 months

MI size measure by CMR

Time frame: 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

Time frame: 3-5 days after PCI and 180±7 days

Secondary Outcomes

Change from baseline incidence of intramyocardial hemorrhagex at 6 months

Incidence of intramyocardial hemorrhagex measure by CMR

Time frame: 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

Time frame: 3-5 days after PCI and 180±7 days

Change of ST segment in electrocardiogram

Time frame: Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days

Change of CK-MB

CK-MB

Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Change of cTnI

cTnI

Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Change of NT-proBNP

NT-proBNP

Time frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Change of ejection fraction in echocardiography

Ejection fraction measure by echocardiography

Time frame: 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

Time frame: 3-5 days after PCI, 30±7 days and 180±7 days

Quantitative flow ratio

Index measure by QFR

Time frame: 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

Time frame: Through study completion, an average of 1 year

Incidence of complications of PCI

Cardiac shock, heart failure, mechanical complications and arrhythmia

Time frame: Up to 1 month

Incidence of bleeding event

BARC Type 3 or 4

Time frame: Up to 6 months

Incidence of stent restenosis

stent restenosis measure by CMR

Time frame: 180±7 days

Incidence of death event

Any death

Time frame: 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.

Time frame: baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts