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Recruiting NCT06769256

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

Phase IV Interventional ST-segment Elevation Myocardial Infarction (STEMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rhTNK-tPA, 4-8 mg, Tirofiban.
Who it may be relevant to
Registry conditions: ST-segment Elevation Myocardial Infarction (STEMI). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Corrected TIMI frame count (CTFC) [Time frame: At the end of Percutaneous Coronary Intervention procedure]
Secondary outcome measures (5)
  • TIMI flow grade [Time frame: At the end of Percutaneous Coronary Intervention procedure]
  • Complete ST-segment resolution (STR) [Time frame: 1 hour post PCI procedure]
  • Left ventricular ejection fraction (LVEF) [Time frame: Baseline, 1 month, 6 months and 12 months]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT06769256 · HenanICE202412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗