Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06769256

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

ST-segment Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

You Zhang

CONTACT

+8637158681037

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhTNK-tPA, 4-8 mg

Drug

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.

tirofiban

Drug

Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer

Primary outcomes

  1. Corrected TIMI frame count (CTFC)

    Time frame: At the end of Percutaneous Coronary Intervention procedure

Secondary outcomes

  1. TIMI flow grade

    Time frame: At the end of Percutaneous Coronary Intervention procedure

  2. Complete ST-segment resolution (STR)

    Time frame: 1 hour post PCI procedure

  3. Left ventricular ejection fraction (LVEF)

    Time frame: Baseline, 1 month, 6 months and 12 months

  4. A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure

    Time frame: 1 month, 6 months and 12 months

  5. Bleeding events according to the BARC bleeding classification

    Time frame: At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

You Zhang

CONTACT

[email protected]

+86 37158681037

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Official study title

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

Acronym: H2-THROMBUS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.