Coronary Artery DiseasePhase 2NCT07397351
Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation
A Phase 2 study testing Aroxxen in people with Coronary Artery Disease, run by Research Institute of Geroprotective Technologies at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aroxxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteRussia
- Study dates
- 5 Mar 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
City Multidisciplinary Hospital No. 2
Saint Petersburg
Boyarkin, MD, ab.59@mail.ru
About this study
Official title: 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 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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Aroxxen
- Keywords
- Myocardial Injury, Percutaneous Coronary Intervention, Stent Implantation, Cardioprotection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AroxxenDrug
Aroxxen® is an investigational medicinal product administered by inhalation during and after elective percutaneous coronary intervention in accordance with the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aroxxen |
| 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. Receives: Drug: Aroxxen |
| Standard Care (No Aroxxen® Inhalation) | No intervention | Patients undergo elective percutaneous coronary intervention with stent implantation without additional inhalation of the investigational medicinal product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline before the start of inhalation to 24 hours after the start of inhalation (with assessments at 4, 12, and 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start5 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Geroprotective Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397351
- Sponsor's protocol ID
- CTARE25/II
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07397351
- Acronym / sponsor ID
- CTARE25/II
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Injury, Percutaneous Coronary Intervention, Stent Implantation, Cardioprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Research Institute of Geroprotective TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aroxxen® Inhalation, Composition Variant 1 | Experimental | Drug: AroxxenPatients 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 | Drug: AroxxenPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AroxxenAroxxen® is an investigational medicinal product administered by inhalation during and after elective percutaneous coronary intervention in accordance with the study protocol. | Drug | Aroxxen® Inhalation, Composition Variant 1, Aroxxen® Inhalation, Composition Variant 2 |
Primary outcome
Incremental area under the concentration-time curve (iAUC) of high-sensitivity troponin I (hs-cTnI)
Time frame: From baseline before the start of inhalation to 24 hours after the start of inhalation (with assessments at 4, 12, and 24 hours).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aroxxen in people with Coronary Artery Disease, run by Research Institute of Geroprotective Technologies at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental area under the concentration-time curve (iAUC) of high-sensitivity troponin I (hs-cTnI) (time frame: From baseline before the start of inhalation to 24 hours after the start of inhalation (with assessments at 4, 12, and 24 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.