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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Kuanxiong Aerosol in Patients with Myocardial Bridging and Angina Pectoris

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Kuanxiong Aerosol in Patients with Myocardial Bridging and Angina Pectoris

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110339
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Myocardial Bridge Complicated by Angina Pectoris

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18–75 years (inclusive), regardless of gender. 2. Patients with angina or anginal equivalent symptoms (pressure-like discomfort in the chest, neck, jaw, shoulder, or arm; precipitated by physical exertion; relieved within 5 minutes by rest or nitroglycerin use) occurring at a frequency of >=2 times per week. 3. Diagnosis: Confirmed myocardial bridge in the left anterior descending (LAD) artery via coronary angiography or coronary CTA, including: (1) Patients with isolated myocardial bridge in the LAD artery; (2) Patients with myocardial bridge in the LAD artery and <50% stenosis in all epicardial coronary arteries. 4. Consent: Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Coronary Stenosis: >=50% stenosis in any epicardial coronary artery confirmed by coronary angiography or coronary CTA. 2. Recent ACS: Diagnosis of acute coronary syndrome (ACS) within the past 12 months. 3. Prior Revascularization: Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the past 12 months. 4. Non-Cardiac Chest Pain: Comorbidities that may cause chest pain (e.g., severe pulmonary hypertension, severe aortic stenosis, or obstructive hypertrophic cardiomyopathy). 5. Severe Anemia: Hemoglobin 180 mmHg or diastolic blood pressure >110 mmHg. 8. Uncontrolled Arrhythmias: Hemodynamically unstable arrhythmias (e.g., rapid atrial fibrillation, supraventricular tachycardia, high-grade atrioventricular block). 9. Recent Medication Use: Use of ß-blockers, calcium channel blockers, Kuanxiong Aerosol, or herbal preparations (e.g., Tongxinluo, Shexiang Baoxin Pills, Compound Danshen Dripping Pills) within 2 weeks prior to enrollment. *Note: A 2-week washout period is required; eligibility may be reassessed thereafter.*; 10. Allergy History: Hypersensitivity to alcohol or components of Kuanxiong Aerosol (including documented allergy or prior allergic reactions). 11. Severe Systemic Diseases: Active malignancy or other severe systemic disorders. 12. Pregnancy: Pregnant women or women planning pregnancy. 13. Concurrent Trials: Participation in another clinical trial or prior randomization in this study within 30 days before screening. 14. Investigator Discretion: Patients deemed ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire (SAQ);

Secondary

MeasureTime frame
Anxiety/Depression Scales: Generalized Anxiety Disorder-7 (GAD-7) Patient Health Questionnaire-9 (PHQ-9);Treadmill Exercise Testing;Frequency of Angina Episodes;Seattle Angina Questionnaire (SAQ);12-Item Short Form Survey (SF-12 );Cardiopulmonary Exercise Testing;

Countries

China

Contacts

Public ContactGe Junbo

Zhongshan Hospital, Fudan University

ge.junbo@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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