NCT06769256

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

Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST-segment Elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
DRUG	rhTNK-tPA, 4-8 mg	Intracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced.
DRUG	Tirofiban	Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2025-01-10
• Last updated: 2025-05-13

Locations

1 site across 1 country: China