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 (PC
| Condition(s) | Coronary Artery Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 1. 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). 2. Clinically and/or hemodynamically significant coronary artery stenosis confirmed by coronary angiography, with an indication for percutaneous coronary intervention with stent implantation. 3. Age 50 to 80 years inclusive at the time of signing informed consent. 4. Baseline high-sensitivity troponin I within the laboratory reference range, excluding acute coronary syndrome. 5. Written voluntary informed consent obtained after the pa |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Lead sponsor | Research Institute of Geroprotective Technologies |
| Locations | Saint Petersburg, Russia |
| Start date | 2026-03-05 |
| NCT ID | NCT07397351 |
| Official listing | https://clinicaltrials.gov/study/NCT07397351 |