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NCT Number: NCT07641231

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

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Moscow, Select A State, 121552, Russia

Location contact

Rimma Gulyan

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

catheterisation

Procedure

Standard primary PCI

Other names: Routine or rescue coronary intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of patients with all-cause mortality

    Time frame: during hospitalization (assessed up to 10 days)

  2. Number of patients with cardiovascular mortality

    Time frame: during hospitalization (assessed up to 10 days)

  3. Number of patients with non-fatal MI

    Time frame: during hospitalization (assessed up to 10 days)

  4. Number of patients with hemorrhagic stroke

    Time frame: during hospitalization (assessed up to 10 days)

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

    Time frame: 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 )

    Time frame: during hospitalization (assessed up to 10 days)

  7. Number of patients with all-cause mortality

    Time frame: 12 months

  8. Number of patients with cardiovascular mortality

    Time frame: 12 months

  9. Number of patients with non-fatal MI

    Time frame: 12 months

  10. Number of patients with hemorrhagic stroke

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Rimma Gulyan

CONTACT

[email protected]

+79152284043

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • AO GENERIUM

Registry information

Official study 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)

Acronym: RAPID-STEMI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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