Macitentan for angina with non-obstructive coronary arteries

Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina

This study will test whether taking macitentan 10 mg daily can reduce chest pain and improve coronary microvascular function in adults who have angina but no obstructive coronary artery disease.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07392281 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-center, single-arm early phase 1 trial testing daily macitentan 10 mg in patients with angina and non-obstructive coronary arteries (ANOCA). Participants undergo invasive coronary microcirculatory assessment using pressure wire–based thermodilution to measure coronary flow reserve (CFR) and index of microcirculatory resistance (IMR), and are classified into functional subtypes. The protocol focuses on changes in microvascular function and symptomatic response while monitoring for known endothelin-receptor antagonist adverse effects such as edema and headache. The single-arm design aims to link mechanistic changes in microcirculatory indices with clinical symptoms in a carefully phenotyped population.

Who should consider this trial

Good fit: Adults aged 18–75 with typical angina, no obstructive coronary lesions on angiography, and confirmed coronary microcirculatory dysfunction by pressure wire thermodilution are the intended participants.

Not a fit: Patients with obstructive coronary artery disease, recent myocardial infarction, severe heart, liver or kidney dysfunction, pregnant or lactating women, or those in other recent drug trials are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, macitentan could reduce angina episodes and improve coronary microvascular blood flow for patients with ANOCA, offering a targeted treatment option where few exist.

How similar studies have performed: Preclinical work and some clinical reports suggest endothelin-receptor antagonists can improve microvascular endothelial function and myocardial perfusion, but prior human studies lacked precise invasive microvascular phenotyping and older drugs had frequent side effects, so evidence is suggestive but not definitive.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yanxiang Gao

Conditions Non-Coronary Obstructive Angina; Coronary microvscular dysfunction; Macitentan; Endothelin-receptor antagonists