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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003252
Enrollment
Unknown
Registered
2020-04-27
Start date
2020-04-23
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary microvascular disease

Interventions

Sponsors

Sir Run Run Shaw Hospital (SRRSH), affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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 = 50%; 4. Type C-F dissection of coronary artery.

Design outcomes

Primary

MeasureTime frame
Index of Microcirculatory Resistance, IMR;

Secondary

MeasureTime frame
Major Adverse Cardiac Events, MACE;Coronary Flow Reserve, CFR;Corrected TIMI Frame Count, CTFC;

Countries

China

Contacts

Public ContactFuyu Qiu

Department of Cardiology, Sir Run Run Shaw Hospital (SRRSH), affiliated to Zhejiang University School of Medicine

qiufuyu@hotmail.com+86 13957103699

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026