China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06811831
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Macitentan 10 mg tablet, once daily.
DrugAfter the patient signed an informed consent form, Macitentan was given as an oral medication (10 mg once daily) for a period of 4 weeks
Primary outcomes
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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)
- 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
Secondary outcomes
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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
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.
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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
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.
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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
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.
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Incidence of rehospitalisation for angina or heart failure.
Time frame: 4-week follow-up; 8-week follow-up
Other outcomes
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Safety Outcome
Time frame: 8-week follow-up
Occurrence of all adverse events such as hydrosodium storage, anaemia, headache and hypotension et al.
Study contacts
Contact information is provided by the study sponsor or research team.
Jingang Zheng
CONTACT
Yanxiang Gao, Study Principal Investigator
CONTACT
Sponsors and collaborators
Lead sponsor
China-Japan Friendship Hospital
Other
Registry information
Official study title
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina: a Pilot Study
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 6, 2025
- Registry last updated
- Feb 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.