Actively Recruiting
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
Led by Henan Institute of Cardiovascular Epidemiology · Updated on 2025-05-13
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old
- STEMI within 12 hours of onset
- TIMI flow grade 0-2 or TIMI thrombus grade 64 after thrombus aspiration or balloon dilation
- Radial artery access
You will not qualify if you...
- A functional coronary collateral supply (Rentrop grade 652) to the infarct-related 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 655 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
You Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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