Effect of Shexiang Tongxin Dropping Pill on Stable Coronary Artery Disease Patients with Normal Fractional Flow Reserve and Coronary Microvascular Disease

Phase 4

Recruiting

• Conditions: Coronary microvascular disease

• Registration Number: ITMCTR2000003252
• Lead Sponsor: Sir Run Run Shaw Hospital (SRRSH), affiliated to Zhejiang University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Clinical inclusion criteria
1. Subjects with stable coronary artery disease,including chronic stable exertional angina,ischemic cardiomyopathy and stable course of disease after acute coronary syndrome (ACS)(The onset was more than 30 days and troponin was negative);
2. Subjects aged 18 to 80 years;
3. Women of childbearing age are not allowed to conceive or plan to conceive during the study period.Subjects are advised to use adequate contraceptive measures until (including) the end of follow-up;
4. Subjects must agree to a 12-month angiographic follow-up and 30-day, 6-month, 9-month, and 12-month clinical follow-up;
5. Subjects are able to understand the purpose of the study psychologically and linguistically, showing sufficient compliance to the research protocol;
6. By providing informed consent, the subjects acknowledge the risks and benefits described in the informed consent document.
Selection criteria for lesions: Coronary angiography shows stenosis >= 50% in at least one of the three main coronary arteries with FFR >= 0.80. No need for revascularization (including balloon inflation, stent implantation, coronary artery bypass grafting, etc.), IMR >= 25.

Exclusion Criteria

Clinical exclusion criteria:
1. Subjects who have undergone revascularization within 12 months;
2. Subjects with severe congestive heart failure or severe heart failure(NYHA class IV);
3. Subjects with severe valvular heart disease;
4. Pregnant or breastfeeding women;
5. Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months;
6. Subjects who suffered a stroke within 6 months before the operation;
7. Subjects with leukopenia (white blood cell count < 3*10^9/L for more than 3 days) or neutropenia (<1000 /mm3 for more than 3 days) or thrombocytopenia (<100,000/mm3);
8. Subjects with hemorrhagic constitution and contraindication to anticoagulants or antiplatelet drugs;
9. Subjects with a history of severe liver failure (ALT or AST exceeds 3 times the upper limit of normal (ULN));
10. Subjects with a history of severe renal failure(eGFR<30ml/min);
11. Subjects with heart transplant;
12. Subjects with cardiogenic shock;
13. Subjects with a left ventricular ejection fraction of less than 30%;
14. Subjects with a life expectancy of not more than 1 year or with difficulties in clinical follow-up;
15. Subjects who have previously taken Shexiang Tongxin Dropping Pill;
16. Subjects who are considered to be unsuitable by researchers for other reasons.
Exclusion criteria for lesions:
1. Thrombotic lesions;
2. Coronary spasm without significant stenosis;
3. Left main disease with a diameter stenosis rate of >= 50%;
4. Type C-F dissection of coronary artery.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Index of Microcirculatory Resistance, IMR;

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events, MACE;Coronary Flow Reserve, CFR;Corrected TIMI Frame Count, CTFC;