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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04814121
• Other study ID #: 2020KT1715
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2021
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Minzhou Zhang, Professor
• Phone: +86-13924266368
• Email: minzhouzhang[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Suxiao Jiuxin Pills
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
• The placebo of Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline myocardial infarct size at 6 months	MI size measure by CMR	3-5 days after PCI and 180±7 days
Primary	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
Secondary	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
Secondary	Change from baseline incidence of area-at-risk at 6 months	Incidence of area-at-risk measure by CMR	3-5 days after PCI and 180±7 days
Secondary	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
Secondary	Change of CK-MB	CK-MB	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Secondary	Change of cTnI	cTnI	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Secondary	Change of NT-proBNP	NT-proBNP	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Secondary	Change of ejection fraction in echocardiography	Ejection fraction measure by echocardiography	Baseline, 3-5 days after PCI and 180±7 days
Secondary	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
Secondary	Quantitative flow ratio	Index measure by QFR	During the procedure
Secondary	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
Secondary	Incidence of complications of PCI	Cardiac shock, heart failure, mechanical complications and arrhythmia	Up to 1 month
Secondary	Incidence of bleeding event	BARC Type 3 or 4	Up to 6 months
Secondary	Incidence of stent restenosis	stent restenosis measure by CMR	180±7 days
Secondary	Incidence of death event	Any death	Through study completion, an average of 1 year
Secondary	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