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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

240 Participants
are divided into 2 treatment groups