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Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation

NCT07397351 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-06

No results posted yet for this study

Summary

This is an open-label, randomized, multicenter Phase II clinical study designed to evaluate the cardioprotective effect, to determine the optimal dosages and duration of inhalation, and to assess the clinical safety of the medicinal product Aroxxen® in patients undergoing elective percutaneous coronary intervention (PCI) with stent implantation.

Patients who undergo elective PCI are at risk of myocardial injury associated with the procedure. The study aims to assess whether inhalation of Aroxxen®, administered during the procedure and after it, can reduce markers of myocardial damage and improve clinical outcomes, while maintaining an acceptable safety profile.

Eligible patients will be randomized to receive inhalation of Aroxxen® according to the study protocol or standard therapy without inhalation, depending on the assigned group. The study includes multiple centers and compares different dosing regimens and durations of inhalation in order to identify optimal treatment parameters.

Safety will be evaluated by monitoring adverse events, vital signs, and clinical laboratory parameters throughout the study period. The results of this study are intended to provide data on the safety and potential cardioprotective effects of Aroxxen® and to support further clinical development.

Conditions

Interventions

DRUG

Aroxxen

Aroxxen® is an investigational medicinal product administered by inhalation during and after elective percutaneous coronary intervention in accordance with the study protocol.

Sponsors & Collaborators

  • Research Institute of Geroprotective Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2026-10-01
Completion
2026-12-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07397351 on ClinicalTrials.gov