Macitentan for angina with non-obstructive coronary arteries
Official title: Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina
Run by China-Japan Friendship Hospital · NCT07392281 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07392281 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yanxiang Gao
- Email: gaoyx1980@163.com
- Phone: +86 13811020048
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.