Aroxxen inhalation to protect the heart during elective stent placement
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)
This trial tests whether inhaled Aroxxen given during and after elective stent procedures can reduce heart muscle damage in people with coronary artery disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Research Institute of Geroprotective Technologies Industry-sponsored |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT07397351 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized, multicenter Phase II trial comparing inhaled Aroxxen given during the percutaneous coronary intervention (PCI) procedure and for a defined period afterward against standard therapy without inhalation. Multiple dosing regimens and durations of inhalation are being tested to identify optimal treatment parameters. Primary outcomes focus on biomarkers of myocardial injury (for example, high-sensitivity troponin) and clinical safety during the peri-procedural period. Patients are randomized at participating centers and followed through defined study visits to monitor efficacy and adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50–80 with coronary artery disease scheduled for elective PCI with stent implantation and a normal baseline high-sensitivity troponin level.
Not a fit: Patients with acute coronary syndrome, elevated baseline troponin, emergency PCI, or those outside the 50–80 age range or unable to comply with inhalation procedures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, Aroxxen inhalation could reduce procedure-related heart muscle injury and improve recovery after elective PCI with stenting.
How similar studies have performed: The inhaled Aroxxen approach is relatively novel and there are limited published data specifically supporting its cardioprotective effect, so prior evidence is sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint Petersburg
- City Multidisciplinary Hospital No. 2 — Saint Petersburg, Russia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.