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Efficacy of Tanyu Tongzhi Capsule in the Treatment of Post-PCI Chest Pain with Microcirculatory Dysfunction: A Multicenter Randomized Double-Blind Placebo-Controlled Study

Efficacy of Tanyu Tongzhi Capsule in the Treatment of Post-PCI Chest Pain with Microcirculatory Dysfunction: A Multicenter Randomized Double-Blind Placebo-Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000859
Enrollment
Unknown
Registered
2025-04-27
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Coronary Heart Disease

Interventions

Treatment group:The conventional Western medical treatment combined with Tanyu Tongzhi Capsule served
Control group:The conventional treatment regimen combined with placebo served

Sponsors

Zhejiang Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Presence of myocardial ischemia symptoms such as chest tightness and/or angina.2.History of percutaneous coronary intervention (PCI) =3 months prior with residual stenosis =50% in major coronary arteries (diameter >2.5 mm).3.Objective evidence of ischemia or microvascular dysfunction defined by at least one of the following:Dynamic ST-T segment changes on electrocardiogram(ECG);Abnormal myocardial perfusion on stress-rest cardiac single-photon emission computed tomography (SPECT);TIMI (Thrombolysis in Myocardial Infarction) flow grade 25;Microvascular resistance reserve (MRR) <2.1.4.Age 18–80 years (inclusive).5Provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1.Cardiovascular Comorbidities:Acute myocardial infarction (AMI) prior myocardial infarction coronary artery spasm dilated cardiomyopathy hypertrophic cardiomyopathy or hypertensive heart disease.2.Impaired Cardiac Function:Left ventricular ejection fraction (LVEF) 3× upper limit of normal [ULN]);Renal insufficiency (serum creatinine =265 µmol/L or eGFR <30 mL/min/1.73 m²);Pulmonary hypertension (mean PAP =25 mmHg);Chronic obstructive pulmonary disease (COPD) GOLD stage =3. 6.Hypersensitivity:Known or suspected hypersensitivity to Tanyu Tongzhi Capsule components;History of severe atopic reactions.7.Pregnancy/Lactation:Current pregnancy planned pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Changes in Seattle Angina Questionnaire (SAQ) Scores Across Time Points Compared to Baseline;

Secondary

MeasureTime frame
Frequency of angina attacks;Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris;Nitroglycerin dosage;Major Adverse Cardiovascular Events;Evaluation of Therapeutic Efficacy on TCM Syndromes;

Countries

China

Contacts

Public ContactJinDai

Zhejiang Provincial Hospital of Traditional Chinese Medicine

dannis606@163.com13588459531

Outcome results

None listed

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