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

June 8, 2026 updated by: Dmitry Pevzner, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
    • Select A State
      • Moscow, Select A State, Russia, 121552
        • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In-hospital thrombolysis in PCI-center
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
Single, weight-adjusted i.v. bolus of tenecteplase in case of >60 min in-hospital delay in PCI center
Procedure: catheterisation
Standard primary PCI
Other Names:
  • Routine or rescue coronary intervention
Active Comparator: Primary PCI in PCI-center
Standard primary PCI in case of predicted delayed pPCI (>60 min after admission in PCI-center).
Procedure: catheterisation
Standard primary PCI
Other Names:
  • Routine or rescue coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Time Frame
Number of patients with all-cause mortality
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with cardiovascular mortality
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with non-fatal MI
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with hemorrhagic stroke
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with major bleeding according to the BARC scale (type 3-5)
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications )
Time Frame: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with all-cause mortality
Time Frame: 12 months
12 months
Number of patients with cardiovascular mortality
Time Frame: 12 months
12 months
Number of patients with non-fatal MI
Time Frame: 12 months
12 months
Number of patients with hemorrhagic stroke
Time Frame: 12 months
12 months
Number of patients with major bleeding according to the BARC scale (type 3-5)
Time Frame: 12 months
12 months
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

AO GENERIUM

Investigators

  • Study Director: Dmitry Pevzner, Doctor of Medical Sciences, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • Principal Investigator: Rimma Gulyan, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

May 20, 2028

Study Completion (Estimated)

May 20, 2029

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 324-2026-04-27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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