ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Brief summary
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
DRUGrhTNK-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.
DRUGTirofiban
Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected TIMI frame count (CTFC) | At the end of Percutaneous Coronary Intervention procedure |
Secondary
| 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 |
Countries
China
Contacts
CONTACTYou Zhang
Outcome results
None listed