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

NCT07641231 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 324-2026-04-27
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

in-hospital fibrinolysis; STEMI; pharmacoinvasive strategy; myocardial infarction (MI); thrombolysis

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

• Number of patients with all-cause mortality

  during hospitalization (assessed up to 10 days)

• Number of patients with cardiovascular mortality

  during hospitalization (assessed up to 10 days)

• Number of patients with non-fatal MI

  during hospitalization (assessed up to 10 days)

• Number of patients with hemorrhagic stroke

  during hospitalization (assessed up to 10 days)

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

  during hospitalization (assessed up to 10 days)

Study Arms (2)

In-hospital thrombolysis in PCI-center

EXPERIMENTAL

In-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.

Drug: Single, weight-adjusted i.v. bolus of tenecteplase; Procedure: catheterisation

Primary PCI in PCI-center

ACTIVE COMPARATOR

Standard primary PCI in case of predicted delayed pPCI (\>60 min after admission in PCI-center).

Procedure: catheterisation

Interventions

Single, weight-adjusted i.v. bolus of tenecteplase DRUG

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

In-hospital thrombolysis in PCI-center

catheterisation PROCEDURE

Standard primary PCI

Also known as: Routine or rescue coronary intervention

In-hospital thrombolysis in PCI-center; Primary PCI in PCI-center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: lead
• AO GENERIUM: collaborator

Study Sites (1)

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

Moscow, Select A State, 121552, Russia

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Interventions

Single Person; Catheterization

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Therapeutics; Investigative Techniques

Study Officials

• Dmitry Pevzner, Doctor of Medical Sciences

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

  STUDY DIRECTOR

• Rimma Gulyan

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rimma Gulyan

CONTACT

+79152284043; rimmagulyan5@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medical Sciences, Professor, Head of the Emergency Cardiology Department

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

RU (1)