drugset / Trial / NCT06769256

Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden

NCT06769256

Phase 4 Recruiting 300 enrolled Henan Institute of Cardiovascular Epidemiology
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are: * Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden? * Does intracoronary rhTNK-tPA increase the incidence of bleeding events? This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.

Timeline

Start
2025-01-01
Primary completion
2027-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenecteplase Protein / enzyme biologic 4 mg
Comparator Tirofiban Other / unclassified 0.075 ug/kg Intravenous
Comparator Tirofiban Other / unclassified 0.15 ug/kg Intravenous