Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation

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.

Recruiting

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City Multidisciplinary Hospital No. 2

Saint Petersburg, Russia

Location status: Recruiting

Location contact

Boyarkin, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Presence of coronary artery disease with stenosis of one or more coronary arteries requiring elective percutaneous coronary intervention for stent implantation (including patients with stable angina pectoris, Canadian Cardiovascular Society functional class II-IV, and patients with post-infarction or atherosclerotic cardiosclerosis with or without angina).
Clinically and/or hemodynamically significant coronary artery stenosis confirmed by coronary angiography, with an indication for percutaneous coronary intervention with stent implantation.
Age 50 to 80 years inclusive at the time of signing informed consent.
Baseline high-sensitivity troponin I within the laboratory reference range, excluding acute coronary syndrome.
Written voluntary informed consent obtained after the participant has received full information about the study objectives, methods, risks, and potential benefits.
Willingness and ability to comply with all study procedures and visits specified in the protocol.

Treatment and study plan

Aroxxen

Drug

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

Primary outcomes

Incremental area under the concentration-time curve (iAUC) of high-sensitivity troponin I (hs-cTnI)

Time frame: From baseline before the start of inhalation to 24 hours after the start of inhalation (with assessments at 4, 12, and 24 hours).

The individual incremental area under the concentration-time curve (iAUC) of high-sensitivity troponin I is calculated for each participant based on serial venous blood measurements obtained at baseline before the start of inhalation and at 4 hours, 12 hours, and 24 hours after the start of inhalation.

Sponsors and collaborators

Lead sponsor

Research Institute of Geroprotective Technologies

Industry

Registry information

Official study title

Open-Label, Randomized, Multicenter Clinical Trial to Evaluate the Cardioprotective Effect, Determine Optimal Dosages and Duration of Inhalation, and Confirm the Clinical Safety of the Medicinal Product Aroxxen® in Patients Who Have Undergone Elective Percutaneous Coronary Intervention With Stent Implantation (Phase II)

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 9, 2026
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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