Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aroxxen® Inhalation, Composition Variant 1 | Experimental | Patients receive inhalation of the investigational medicinal product Aroxxen® (composition variant 1) during and after elective percutaneous coronary intervention with stent implantation, according to the study protocol. |
|
| Aroxxen® Inhalation, Composition Variant 2 | Experimental | Patients receive inhalation of the investigational medicinal product Aroxxen® (composition variant 2) during and after elective percutaneous coronary intervention with stent implantation, according to the study protocol. |
|
| Standard Care (No Aroxxen® Inhalation) | No Intervention | Patients undergo elective percutaneous coronary intervention with stent implantation without additional inhalation of the investigational medicinal product. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aroxxen | Drug | Aroxxen® is an investigational medicinal product administered by inhalation during and after elective percutaneous coronary intervention in accordance with the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the concentration-time curve (iAUC) of high-sensitivity troponin I (hs-cTnI) | 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. | From baseline before the start of inhalation to 24 hours after the start of inhalation (with assessments at 4, 12, and 24 hours). |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Multidisciplinary Hospital No. 2 | Recruiting | Saint Petersburg | Russia |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |