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Recruiting NCT07397351

Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation

Phase II Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aroxxen.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug Aroxxen
    Aroxxen® is an investigational medicinal product administered by inhalation during and after elective percutaneous coronary intervention in accordance with the study protocol.

Primary outcome measures

  • 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).]

Eligibility criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Russia · 1 center
  • City Multidisciplinary Hospital No. 2 — Saint Petersburg

Identifiers

NCT: NCT07397351 · CTARE25/II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗