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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
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.
Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
RECRUITINGCorrected TIMI frame count (CTFC)
Time frame: At the end of Percutaneous Coronary Intervention procedure
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
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