Coronary MicrovAscular Diseases Intervention With Compound Danshen Dropping Pills

Korábbi kezelés

• Acute myocardial infarction within 1 month prior to randomization.
• Unstable angina within 1 week prior to randomization.
• Hemorrhagic stroke within the previous 6 months.
• Current requirement for anticoagulation therapy with warfarin; current use of nicorandil; or concomitant treatment with other traditional Chinese medicine (TCM) preparations.
• Participation in another interventional clinical trial within 3 months prior to randomization or concurrent participation in another clinical study.

Más betegség

• Persistent or permanent atrial fibrillation; clinically significant bradyarrhythmias (including severe sinus bradycardia or second-degree type II or higher atrioventricular block); sinus node dysfunction; uncontrolled chronic obstructive pulmonary disease (COPD); or uncontrolled bronchial asthma.
• Uncontrolled hypertension, defined as systolic blood pressure (SBP) >150 mmHg and/or diastolic blood pressure (DBP) >90 mmHg despite appropriate medical management.
• Clinically significant respiratory, gastrointestinal, hematologic, infectious, immunologic, endocrine, neurological, psychiatric, or malignant diseases that, in the investigator's judgment, may pose an unacceptable risk to the participant or interfere with study participation.
• Known or suspected hypersensitivity to intra-arterial contrast media, blood or blood products, or the investigational medicinal product.
• Any other medical condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for enrollment in this study.

Laborértékek

• Severe valvular heart disease, cardiomyopathy, LVEF <50%, Takayasu arteritis, or aortic dissection.
• Hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 ×ULN) or renal impairment (estimated glomerular filtration rate [eGFR] ≤60 mL/min/1.73m²).
• Active bleeding or clinically significant bleeding tendency, including platelet count <50×10⁹/L or documented coagulation disorders.

Egyéb

• Pregnant, planning pregnancy, or breastfeeding.

• Male or female participants aged 18 to 80 years (inclusive).
• Within 6 months prior to randomization, coronary computed tomography angiography(CTA) or angiography demonstrating coronary stenosis ≤50%, or residual stenosis ≤50% after revascularization, or stenosis >50% with FFR >0.8.
• CFR of the left anterior descending（LAD） artery measured by transthoracic Doppler echocardiography（TTE） <2.5.
• Clinical diagnosis of CMVD, meeting any one of the following categories:
  • （1）Ischemia-related CMVD:
• Myocardial Ischemia with Non-Obstructive Coronary Arteries: Presence of symptoms consistent with chronic myocardial ischemia, together with objective evidence of reduced CFR and/or coronary microvascular spasm, in the absence of obstructive epicardial coronary artery disease.
  • ②Myocardial Ischemia with obstructive Coronary Arteries: Following successful treatment of epicardial coronary artery stenosis with residual luminal stenosis ≤50%, TTE demonstrates persistent impairment of CFR <2.5 in the LAD.
  • （2）Myocardial infarction-related CMVD:
• Myocardial infarction with non-obstructive coronary arteries (MINOCA): Coronary CTA or invasive coronary angiography demonstrates coronary artery stenosis ≤50%.
  • Myocardial infarction with obstructive coronary arteries (MIOCA): Typically associated with coronary microvascular obstruction, including but not limited to ST-segment elevation myocardial infarction (STEMI) complicated by coronary microvascular obstruction.
  • 5.Voluntary provision of written informed consent by the subject or legal representative.