Evaluating Macitentan for treating coronary microvascular angina
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina: a Pilot Study
This study is testing if a medication called Macitentan can help people with coronary microvascular angina feel better and improve their heart function.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06811831 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the efficacy of Macitentan, an endothelin receptor antagonist, in patients suffering from coronary microvascular angina, a condition that significantly impacts quality of life and is currently without effective treatments. Participants aged 18-75 with typical angina symptoms and specific coronary microcirculatory dysfunction will receive a daily dose of Macitentan. The study will focus on evaluating improvements in symptoms and coronary microvascular function, addressing limitations of previous trials that relied on conventional angiography. The study seeks to provide a more direct assessment of treatment effects on microvascular function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with typical angina symptoms and non-obstructive coronary lesions.
Not a fit: Patients with severe heart disease, renal impairment, or those who have recently participated in other drug trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from coronary microvascular angina.
How similar studies have performed: While previous studies have shown potential benefits of endothelin receptor antagonists, this specific approach focusing on coronary microvascular function is relatively novel.
Eligibility criteria
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 CFR\<2.5 and/or IMR\>25 assessed by temperature dilution method. 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, Study Principal Investigator
- Email: gaoyx1980@163.com
- Phone: +86 13811020048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.