NCT07397351RecruitingPhase 2
Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation
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)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 5 Mar 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Research Institute of Geroprotective Technologies
- Diseases
- Coronary artery disease
- NCT number
- NCT07397351
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 5 Mar 2026 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City Multidisciplinary Hospital No. 2 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.