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New treatment option for Coronary Artery Disease
Official title Aroxxen® Inhalation for Cardioprotection After Elective PCI With Stent Implantation
ClinicalTrials.gov ID: NCT07397351
What this study is testing
What is Aroxxen?
Aroxxen is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Presence of coronary artery disease with stenosis of one or more coronary arteries requiring elective percutaneous coronary intervention for stent...
- Clinically and/or hemodynamically significant coronary artery stenosis confirmed by coronary angiography, with an indication for percutaneous...
- 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...
See the full 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.