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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Microvascular Angina Macitentan

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Taking Macitentan Group

Group Type EXPERIMENTAL

Macitentan 10 mg tablet, once daily.

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No