Not Yet RecruitingPhase 4

Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI

Russia240 participantsStarted 2026-05-20

Plain-language summary

This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (\>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age equal or greater than 18 years * "Symptom onset-randomization" time interval \<12 hours * Predicted "diagnosis-pPCI" time interval equal or greater than 120 minutes * Predicted "admission-pPCI" time interval equal or greater than 60 minutes * Informed consent received Exclusion Criteria: * Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically for STEMI patients who face predicted in-hospital delays before getting primary PCI — does my situation actually involve that kind of delay, and is that why you're considering this trial for me?
2Since this is a Phase 4 trial, the treatments involved have already been approved, but how does the reperfusion approach being tested here compare to what you would normally do for me right now as standard care?
3The trial tracks serious outcomes like cardiovascular death, stroke, and another heart attack over 12 months — what does that tell us about the level of risk involved, and how would my care be monitored over that full year?
4The trial isn't recruiting yet, so there's no guarantee of when it would open or whether I'd be eligible when it does — given how urgent STEMI treatment is, what would my treatment plan be in the meantime?
5Are there other already-available reperfusion strategies you'd recommend I consider now, rather than waiting to see if this trial opens and if I might be a candidate for it?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.

Timeframe: From enrollment to the end of follow-up (12 months).

Trial details

NCT IDNCT07641231

SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-05-20

Contact for this trial

Rimma Gulyan

+79152284043 rimmagulyan5@mail.ru

View on ClinicalTrials.gov More STEMI - ST Elevation Myocardial Infarction trials