Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden (H2-THROMBUS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: rhTNK-tPA, 4-8 mg; Drug: Tirofiban

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: You Zhang; Phone Number: +86 37158681037; Email: 13598019682@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Fuwai Central China Cardiovascular Hospital
      • Contact: You Zhang; Phone Number: +8637158681037

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-75 years old;
• STEMI within 12 hours of onset;
• TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
• Radial artery access

Exclusion Criteria:

• A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
• Known or suspected old myocardial infarction of target vessels
• Rescue PCI
• Cardiogenic shock
• Contraindications to Tirofiban or rhTNK-tPA
• Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate <30ml/min/1.73m2, or on dialysis)
• Prolonged (> 10 minutes) cardiopulmonary resuscitation
• Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
• Severe chronic obstructive pulmonary disease or respiratory failure
• Severe infection
• Neurological disorders
• Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracoronary rhTNK-tPA	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.
Active Comparator: Intracoronary Tirofiban	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corrected TIMI frame count (CTFC)	At the end of Percutaneous Coronary Intervention procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
TIMI flow grade	At the end of Percutaneous Coronary Intervention procedure
Complete ST-segment resolution (STR)	1 hour post PCI procedure
Left ventricular ejection fraction (LVEF)	Baseline, 1 month, 6 months and 12 months
A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure	1 month, 6 months and 12 months
Bleeding events according to the BARC bleeding classification	At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Aromatic; Amino Acids, Cyclic; Tyrosine; Tirofiban
• Other Study ID Numbers: HenanICE202412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No