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

RecruitingPhase 4Ages 18 Years - 75 YearsAllHenan Institute of Cardiovascular Epidemiology
NCT06769256 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • rhTNK-tPA, 4-8 mg
  • Tirofiban
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Where

1 site
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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