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Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation

RecruitingPhase 2Ages 50 Years - 80 YearsAllResearch Institute of Geroprotective Technologies
NCT07397351 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dif

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📋 Eligibility rules (as published)
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 participant has received full information about the study objectives, methods, risks, and potential benefits. 6. Willingness and ability to comply with all study procedures and visits specified in the protocol.
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What it tests

  • Aroxxen
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Where

1 site
City Multidisciplinary Hospital No. 2
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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