Non-Coronary Obstructive AnginaEarly Phase 1MAC-NOCANCT07392281
Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina
A Early Phase 1 study testing Macitentan 10 mg tablet, once daily. in people with Non-Coronary Obstructive Angina, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Coronary Obstructive Angina
- What is being tested?
- Macitentan 10 mg tablet, once daily.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jingang Zheng, +86-10-84205762, mdjingangzheng@yeah.net
About this study
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 will conduct an open-label, single-center, single-arm trial using invasive coronary microcirculatory function testing to accurately phenotype ANOCA and assess microvascular changes. Patients on standard therapy will receive macitentan-a novel ETR antagonist with improved vasodilatory efficacy and safety-to evaluate its effects on coronary microcirculatory function, angina symptoms, and adverse events. Additionally, the investigators will perform multi-omics profiling (proteomics, transcriptomics, metabolomics) on patient blood samples to identify molecular signatures linked to ANOCA subtypes and treatment response, providing evidence for precision intervention strategies in ANOCA.
- Conditions
- Non-Coronary Obstructive Angina
- Being tested
- Macitentan 10 mg tablet, once daily.
- Keywords
- Non-Coronary Obstructive Angina, Coronary microvscular dysfunction, Macitentan, Endothelin-receptor antagonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macitentan 10 mg tablet, once daily.Drug
After the patient signed an informed consent form, Macitentan was given as an oral medication (10 mg once daily) for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taking Macitentan Group | Experimental | Not described Receives: Drug: Macitentan 10 mg tablet, once daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in coronary microcirculation function parameters assessed by CFR from baseline to week 4
Coronary Flow Reserve (CFR): A unitless ratio quantifying maximal coronary blood flow augmentation capacity, measured via thermodilution as the ratio of hyperemic to resting coronary flow. The commonly used cut-off value is 2.0 or 2.5. Increased ratio indicates improved microvascular dilation capacity.
Measured: the duration of hospital stay, an expected average of 1 week; 4-week follow-up
Changes in coronary microcirculation function parameters assessed by IMR from baseline to week 4
Index of Microcirculatory Resistance (IMR): A pressure-derived metric (units: mmHg·s) assessing microvascular resistance using thermodilution, calculated as distal coronary pressure multiplied by mean transit time during maximal hyperemia. The commonly used cut-off value is 25. Decreased value indicates reduced microvascular resistance.
Measured: the duration of hospital stay, an expected average of 1 week; 4-week follow-up
Secondary outcomes (2)
Change in Score of the Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a 19-item instrument designed to assess the impact of angina on patients' daily lives across five domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each item is scored on a 0-100 scale, where higher scores indicate fewer symptoms and better quality of life.
Measured: Endpoint events before administration of macitentan, 1 week and 4 weeks after administration, and 4 weeks after drug withdrawal.
Re-hospitalization due to angina pectoris or heart failure, myocardial infarction, and cardiac death.
Measured: Endpoint events at 1 week and 4 weeks after administration of macitentan, and 4 weeks after drug withdrawal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Coronary Obstructive AnginaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingang Zheng, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392281
- Sponsor's protocol ID
- 2025-KY-351
- Acronym
- MAC-NOCA
- Status last verified
- Dec 2025
- First submitted
- 22 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina
- ClinicalTrials.gov ID
- NCT07392281
- Acronym / sponsor ID
- MAC-NOCA / 2025-KY-351
- Conditions
- Non-Coronary Obstructive Angina
- Keywords
- Non-Coronary Obstructive Angina, Coronary microvscular dysfunction, Macitentan, Endothelin-receptor antagonists
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 will conduct an open-label, single-center, single-arm trial using invasive coronary microcirculatory function testing to accurately phenotype ANOCA and assess microvascular changes. Patients on standard therapy will receive macitentan-a novel ETR antagonist with improved vasodilatory efficacy and safety-to evaluate its effects on coronary microcirculatory function, angina symptoms, and adverse events. Additionally, the investigators will perform multi-omics profiling (proteomics, transcriptomics, metabolomics) on patient blood samples to identify molecular signatures linked to ANOCA subtypes and treatment response, providing evidence for precision intervention strategies in ANOCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taking Macitentan Group | Experimental | Drug: Macitentan 10 mg tablet, once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macitentan 10 mg tablet, once daily.After the patient signed an informed consent form, Macitentan was given as an oral medication (10 mg once daily) for a period of 4 weeks | Drug | Taking Macitentan Group |
Primary outcome
Changes in coronary microcirculation function parameters assessed by CFR from baseline to week 4
Time frame: the duration of hospital stay, an expected average of 1 week; 4-week follow-up
Coronary Flow Reserve (CFR): A unitless ratio quantifying maximal coronary blood flow augmentation capacity, measured via thermodilution as the ratio of hyperemic to resting coronary flow. The commonly used cut-off value is 2.0 or 2.5. Increased ratio indicates improved microvascular dilation capacity.
Changes in coronary microcirculation function parameters assessed by IMR from baseline to week 4
Time frame: the duration of hospital stay, an expected average of 1 week; 4-week follow-up
Index of Microcirculatory Resistance (IMR): A pressure-derived metric (units: mmHg·s) assessing microvascular resistance using thermodilution, calculated as distal coronary pressure multiplied by mean transit time during maximal hyperemia. The commonly used cut-off value is 25. Decreased value indicates reduced microvascular resistance.
2 secondary outcomes
Change in Score of the Seattle Angina Questionnaire (SAQ)
Time frame: Endpoint events before administration of macitentan, 1 week and 4 weeks after administration, and 4 weeks after drug withdrawal.
Re-hospitalization due to angina pectoris or heart failure, myocardial infarction, and cardiac death.
Time frame: Endpoint events at 1 week and 4 weeks after administration of macitentan, and 4 weeks after drug withdrawal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Macitentan 10 mg tablet, once daily. in people with Non-Coronary Obstructive Angina, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanxiang Gao (+86 13811020048, gaoyx1980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in coronary microcirculation function parameters assessed by CFR from baseline to week 4 (time frame: the duration of hospital stay, an expected average of 1 week; 4-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.