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

Phase 4Not Yet RecruitingNCT07641231

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation240 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

STEMI - ST Elevation Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).