Clinical Trial

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

Study acronym: H2-THROMBUS
Recruiting Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-09; most recent amendment 2026-05-19.
Status change: Not Yet Recruiting → Recruiting 2025-05-08
Trial Details
NCT Number NCT06769256
Lead Sponsor Henan Institute of Cardiovascular Epidemiology
Conditions ST-segment Elevation Myocardial Infarction (STEMI)
Enrollment 300 participants
Start Date 2025-01-01
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22