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Not yet recruiting NCT07641231

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

Phase IV Interventional STEMI - ST Elevation Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single, weight-adjusted i.v. bolus of tenecteplase, catheterisation.
Who it may be relevant to
Registry conditions: STEMI - ST Elevation Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation — Moscow

Identifiers

NCT: NCT07641231 · 324-2026-04-27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗