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Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina

RecruitingEARLY Phase 1Ages 18 Years - 75 YearsAllChina-Japan Friendship Hospital
NCT07392281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Angina with non-obstructive coronary arteries (ANOCA) is highly prevalent, impairing quality of life and independently associated with cardiovascular events, yet effective treatments are lacking. The endothelin-1 (ET-1)-endothelin receptor (ETR) system is pivotal in ANOCA pathogenesis. Preclinical studies show that ETR blockade or pericyte-specific knockout of ETA receptor improves coronary microcirculatory function in models of myocardial ischemia-reperfusion and diabetes. Clinical evidence indicates ETR antagonists can enhance microvascular endothelial function and myocardial perfusion in ANOCA patients. However, prior studies diagnosed ANOCA based only on symptoms and angiography without precise microvascular functional assessment. Early ETR antagonists also showed frequent adverse effects (e.g., edema, headache), reducing treatment satisfaction. To address this, the investigators wil

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-75 years old. * With typical angina symptoms. * Excluding obstructive coronary lesions (coronary stenosis ≤50% or FFR ≥0.8) by CAG. * Coronary microcirculatory function was confirmed via pressure wire-based thermodilution technique.（Patients were classified into subtypes based on coronary microcirculatory function indices: 1) Type I: CFR ≥ 2.5 and IMR \< 25; 2) Type II: CFR ≥ 2.5 and IMR ≥ 25; 3) Type III: CFR \< 2.5 and IMR \< 25; 4) Type IV: CFR \< 2.5 and IMR ≥ 25.） * Sign a written informed consent form. Exclusion Criteria: * Pregnant or lactating women. * History of heart attack within the last 90 days. * Severe heart disease (e.g., moderate to severe heart failure, severe heart valve disease). * Severe renal impairment (GFR \<30 ml/min/1.73m2). * Severe liver disease (Child-Pugh class C). * Moderately severe anaemia (haemoglobin concentration \<90 g/L). * Participation in another drug intervention trial study within the last 90 days.
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What it tests

  • Macitentan 10 mg tablet, once daily.
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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