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

NCT07641231 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-06-11

No results posted yet for this study

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

Interventions

DRUG

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

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

PROCEDURE

catheterisation

Standard primary PCI

Sponsors & Collaborators

  • AO GENERIUM

    collaborator INDUSTRY

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

    lead OTHER_GOV

Principal Investigators

  • Dmitry Pevzner, Doctor of Medical Sciences · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2028-05-20
Completion
2029-05-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641231 on ClinicalTrials.gov