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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Standard primary PCI

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: In-hospital thrombolysis in PCI-centerExperimental treatment 2 interventions
Group B: Primary PCI in PCI-centerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.

Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.

Time frame
From enrollment to the end of follow-up (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)

Other outcomes

Sponsors and contacts

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