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A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Exploratory Clinical Trial on the Efficacy of Rapid-acting in the Treatment of Microvascular Angina

A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Exploratory Clinical Trial on the Efficacy of Rapid-acting in the Treatment of Microvascular Angina

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001046
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Microvascular angina

Interventions

Experimental Group:Basic treatment for microvascular angina + Suxiao Jiuxin Wan. Take 6 pills of Suxiao Jiuxin Wan each time, 3 times a day, sublingual administration.
Placebo group:Basic treatment for microvascular angina + simulated. Simulated, 6 tablets each time, 3 times a day, sublingual administration.

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) According to the "International standardization of diagnostic criteria for microvascular angina" published in the "International Journal of Cardiology", there are symptoms related to myocardial ischemia and objective evidence, and coronary angiography confirms that the coronary artery diameter reduction is less than 50% or FFR is greater than 0.80, and the caIMR (coronary artery intrinsic myocardial remodeling index) detected by the coronary artery function measurement system based on coronary angiography is = 25; (2) The patient must be greater than 40 years old and less than 75 years old. (3) The patient must voluntarily participate in this clinical trial, understand, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who have accepted or are expected to accept implantable devices (e.g., ICD, CRT) during the trial period, or those who have undergone revascularization (e.g., PCI, CABG) within the past 3 months, or other cardiac/cardiovascular surgeries; (2) Other coronary microvascular diseases (CMVD) related to myocardial infarction (SPECT can provide exclusion evidence); (3) Patients with severe primary diseases of the liver, kidneys, hematopoietic system, tumors, or other uncontrolled systemic diseases; (4) Patients with variant angina, restrictive cardiomyopathy, hypertrophic (obstructive) cardiomyopathy, uncontrolled arrhythmias, active myocarditis, constrictive pericarditis, or myocardial damage mediated by immune and inflammatory factors; (5) Patients with mental disorders or cognitive dysfunction; (6) Patients with ALT, AST = 1.5 times the upper limit of normal, Scr > 1.2 times normal, or uncorrectable potassium abnormalities; (7) Patients with uncontrolled hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg); (8) Patients with a history of allergies, or known allergies to components of the treatment drugs; (9) Pregnant women, those planning pregnancy, or breastfeeding women; (10) Patients who have participated in other drug clinical studies within the past 3 months; (11) Patients deemed by the investigator to be unable to understand and/or comply with the study drug, procedures, or other situations that would prevent the patient from completing the study, as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Summed Difference Score;

Secondary

MeasureTime frame
Total Perfusion Defect;Summed Stress Score;Summed Rest Score;Ejection Fraction;End- Diastolic Volume;End-Systolic Volume;Stroke Volume;Peak Filling Rate;Phase Histogram Bandwidth;Phase Standard Deviation;Seattle Angina Questionnaire Score;Visual Analogue Scale score for angina;Coronary Heart Disease Qi stagnation and blood stasis syndrome score;Flow Mediated Slowing rate (FMS%);Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs);

Countries

China

Contacts

Public ContactHu Jingqing

Tianjin University of Traditional Chinese Medicine

hjq@tjutcm.edu.cn13911546633

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026