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Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)

RecruitingEARLY Phase 1Ages 18 Years - 75 YearsAllChina-Japan Friendship Hospital
NCT06811831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Macitentan 10 mg tablet, once daily.
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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