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

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Suxiao Jiuxin Pills; Drug: The placebo of Suxiao Jiuxin Pills

• Registration Number: NCT04814121
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24
• Study Start: 2021-05-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suxiao Jiuxin Pills	Suxiao Jiuxin Pills	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	The placebo of Suxiao Jiuxin Pills	The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Quantitative flow ratio	During the procedure	Index measure by QFR
Change of CK-MB	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days	CK-MB
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 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
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.