Coronary Microvascular AnginaEarly Phase 1NCT06811831
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)
A Early Phase 1 study testing Macitentan 10 mg tablet, once daily. in people with Coronary Microvascular Angina and Macitentan, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Coronary microvascular angina (MVA) significantly reduces quality of life and increases the risk of heart problems in patients with angina. Unfortunately, there are no effective treatments available yet. The endothelin-1 (ET-1) - endothelin receptor (ETRs) system plays a critical role in MVA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Microvascular Angina, Macitentan
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Oct 2026
- 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 CFR<2.5 and/or IMR>25 assessed by temperature dilution method.
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, 100000
Jingang Zheng, +86-10-84205762, mdjingangzheng@yeah.net
About this study
Official title: Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina: a Pilot Study
Coronary microvascular angina (MVA) significantly reduces quality of life and increases the risk of heart problems in patients with angina. Unfortunately, there are no effective treatments available yet. The endothelin-1 (ET-1) - endothelin receptor (ETRs) system plays a critical role in MVA. Preclinical studies demonstrate that ETRs antagonists or pericyte-specific knockdown of ETRs can improve coronary microvascular function in myocardial ischemia/reperfusion mice and diabetic mice. Foreign clinical drug trials have shown that ETRs antagonists may alleviate patients' symptoms. However, these studies predominantly rely on conventional coronary angiography rather than direct assessment of coronary microvascular function. Early experimental trials using ETRs antagonists reported a high incidence of side effects, such as sodium retention and headaches, which negatively impacted treatment satisfaction.
To address these limitations, a pilot study is proposed to evaluate the efficacy of macitentan in MVA treatment. This investigation will implement thermodilution-based coronary microcirculation function testing to precisely characterize the severity and subtype of coronary microvascular lesions in MVA patients. By administering macitentan - a safer ETRs antagonist - the study aims to systematically assess improvements in coronary microvascular function, angina symptom relief, and adverse event incidence. The findings are expected to provide critical evidence regarding the therapeutic potential and safety profile of macitentan, while establishing foundational data for subsequent large-scale clinical trials.
- Conditions
- Coronary Microvascular Angina, Macitentan
- Being tested
- Macitentan 10 mg tablet, once daily.
- Keywords
- coronary microvascular angina, angina with non-obstructive coronary arteries, 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.
Change From Baseline to Week 4 in the Coronary Microcirculatory Function Indices Assessed by CFR and IMR
Coronary microcirculatory function indices include Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR)
- 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
- 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 2 weeks; 4-week follow-up
Secondary outcomes (4)
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: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Change in Angina Symptoms Assessed by Angina Diary
The angina diary is a structured log where patients record angina episodes, including their frequency, severity, duration, and possible triggers. Symptom severity is classified using a 4-level grading system similar to the Canadian Cardiovascular Society (CCS) angina.
Measured: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Change in the Score of 6-minute Walking Distance (6MWD)
The 6MWD test evaluates functional exercise capacity by measuring the total distance a patient can walk on a flat surface in 6 minutes. The test reflects cardiovascular fitness and symptom severity.
Measured: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Incidence of rehospitalisation for angina or heart failure.
Measured: 4-week follow-up; 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular 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
- 30 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
- NCT06811831
- Sponsor's protocol ID
- 2024-KY-0501
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 6 Feb 2025
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina: a Pilot Study
- ClinicalTrials.gov ID
- NCT06811831
- Acronym / sponsor ID
- 2024-KY-0501
- Conditions
- Coronary Microvascular Angina, Macitentan
- Keywords
- coronary microvascular angina, angina with non-obstructive coronary arteries, Macitentan, Endothelin-receptor antagonists
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
Coronary microvascular angina (MVA) significantly reduces quality of life and increases the risk of heart problems in patients with angina. Unfortunately, there are no effective treatments available yet. The endothelin-1 (ET-1) - endothelin receptor (ETRs) system plays a critical role in MVA. Preclinical studies demonstrate that ETRs antagonists or pericyte-specific knockdown of ETRs can improve coronary microvascular function in myocardial ischemia/reperfusion mice and diabetic mice. Foreign clinical drug trials have shown that ETRs antagonists may alleviate patients' symptoms. However, these studies predominantly rely on conventional coronary angiography rather than direct assessment of coronary microvascular function. Early experimental trials using ETRs antagonists reported a high incidence of side effects, such as sodium retention and headaches, which negatively impacted treatment satisfaction.
To address these limitations, a pilot study is proposed to evaluate the efficacy of macitentan in MVA treatment. This investigation will implement thermodilution-based coronary microcirculation function testing to precisely characterize the severity and subtype of coronary microvascular lesions in MVA patients. By administering macitentan - a safer ETRs antagonist - the study aims to systematically assess improvements in coronary microvascular function, angina symptom relief, and adverse event incidence. The findings are expected to provide critical evidence regarding the therapeutic potential and safety profile of macitentan, while establishing foundational data for subsequent large-scale clinical trials.
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 (4 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 CFR<2.5 and/or IMR>25 assessed by temperature dilution method.
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
Change From Baseline to Week 4 in the Coronary Microcirculatory Function Indices Assessed by CFR and IMR
Time frame: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up
Coronary microcirculatory function indices include Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) 1. 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 2. 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
4 secondary outcomes
Change in Score of the Seattle Angina Questionnaire (SAQ)
Time frame: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Change in Angina Symptoms Assessed by Angina Diary
Time frame: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Change in the Score of 6-minute Walking Distance (6MWD)
Time frame: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up; 8-week follow-up
Incidence of rehospitalisation for angina or heart failure.
Time frame: 4-week follow-up; 8-week follow-up
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 2025.
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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 Coronary Microvascular Angina and Macitentan, 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 4 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 2025. 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, Study Principal Investigator (+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?
Change From Baseline to Week 4 in the Coronary Microcirculatory Function Indices Assessed by CFR and IMR (time frame: the duration of hospital stay, an expected average of 2 weeks; 4-week follow-up). 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 2025.