AzTrials
AzTrials

STEMI - ST Elevation Myocardial InfarctionPhase 4RAPID-STEMINCT07641231

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

A Phase 4 study testing Single, weight-adjusted i.v. bolus of tenecteplase and catheterisation in people with STEMI - ST Elevation Myocardial Infarction, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Single, weight-adjusted i.v. bolus of tenecteplase and catheterisation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteRussia
Study dates
20 May 2026to 20 May 2029
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rimma Gulyan contact

+79152284043

rimmagulyan5@mail.ru

Russia1 site

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

    Moscow, Select A State, 121552

    Rimma Gulyan, rimmagulyan5@mail.ru

Other trials in Russia

About this study

Official title: A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)

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.

Being tested
Single, weight-adjusted i.v. bolus of tenecteplase, catheterisation
Keywords
in-hospital fibrinolysis, STEMI, pharmacoinvasive strategy, myocardial infarction (MI), thrombolysis
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single, weight-adjusted i.v. bolus of tenecteplaseDrug

    Single, weight-adjusted i.v. bolus of tenecteplase in case of >60 min in-hospital delay in PCI center

  • catheterisationProcedure or surgery

    Also called Routine or rescue coronary intervention

    Standard primary PCI

Study groups in NCT07641231
Study groupRoleWhat they receive
In-hospital thrombolysis in PCI-centerExperimentalIn-hospital thrombolysis with tenecteplase in case of predicted delayed pPCI (>60 min after admission in PCI-center). Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention.
Receives: Drug: Single, weight-adjusted i.v. bolus of tenecteplase; Procedure: catheterisation
Primary PCI in PCI-centerActive comparatorStandard primary PCI in case of predicted delayed pPCI (>60 min after admission in PCI-center).
Receives: Procedure: catheterisation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.

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

Secondary outcomes (12)

  1. Number of patients with all-cause mortality

    Measured: during hospitalization (assessed up to 10 days)

  2. Number of patients with cardiovascular mortality

    Measured: during hospitalization (assessed up to 10 days)

  3. Number of patients with non-fatal MI

    Measured: during hospitalization (assessed up to 10 days)

  4. Number of patients with hemorrhagic stroke

    Measured: during hospitalization (assessed up to 10 days)

  5. Number of patients with major bleeding according to the BARC scale (type 3-5)

    Measured: during hospitalization (assessed up to 10 days)

  6. Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications )

    Measured: during hospitalization (assessed up to 10 days)

  7. Number of patients with all-cause mortality

    Measured: 12 months

  8. Number of patients with cardiovascular mortality

    Measured: 12 months

  9. Number of patients with non-fatal MI

    Measured: 12 months

  10. Number of patients with hemorrhagic stroke

    Measured: 12 months

  11. Number of patients with major bleeding according to the BARC scale (type 3-5)

    Measured: 12 months

  12. Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start20 May 2026 (estimated)
  3. Primary completion20 May 2028 (estimated)
  4. Study completion20 May 2029 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07641231
Sponsor's protocol ID
324-2026-04-27
Acronym
RAPID-STEMI
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Single, weight-adjusted i.v. bolus of tenecteplase and catheterisation in people with STEMI - ST Elevation Myocardial Infarction, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation 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?

The sponsor lists 5 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 11 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Rimma Gulyan (+79152284043, rimmagulyan5@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS. (time frame: From enrollment to the end of follow-up (12 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07641231.

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 11 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in