Actively Recruiting
Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation
Led by Research Institute of Geroprotective Technologies · Updated on 2026-05-06
180
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of coronary artery disease with stenosis requiring elective PCI for stent implantation, including stable angina and post-infarction or atherosclerotic cardiosclerosis with or without angina
- Clinically or hemodynamically significant coronary artery stenosis confirmed by coronary angiography with indication for PCI and stent implantation
- Age 50 to 80 years inclusive at informed consent
- Baseline high-sensitivity troponin I within normal laboratory range, excluding acute coronary syndrome
- Written voluntary informed consent obtained after full information about the study
- Willingness and ability to comply with all study procedures and visits
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City Multidisciplinary Hospital No. 2
Saint Petersburg, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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