Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT06811831

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

Led by China-Japan Friendship Hospital · Updated on 2025-02-06

30

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years old
  • Typical angina symptoms
  • No obstructive coronary lesions (stenosis ≤50% or FFR ≥0.8) confirmed by coronary angiography
  • Coronary microcirculatory function with coronary flow reserve <2.5 and/or index of microcirculatory resistance >25 assessed by thermodilution
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Heart attack within the last 90 days
  • Severe heart diseases such as moderate to severe heart failure or severe heart valve disease
  • Severe kidney impairment (GFR <30 ml/min/1.73m²)
  • Severe liver disease (Child-Pugh class C)
  • Moderate to severe anemia (hemoglobin <90 g/L)
  • Participation in another drug trial within the last 90 days

AI-Screening

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Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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Research Team

Y

Yanxiang Gao, Study Principal Investigator

CONTACT

J

Jingang Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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