Actively Recruiting
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
Led by Henan Institute of Cardiovascular Epidemiology · Updated on 2026-05-22
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effects and safety of two treatments, intracoronary recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) and Tirofiban, in patients who have ST-segment elevation myocardial infarction (STEMI) with a high amount of blood clot. The study aims to find out if rhTNK-tPA works as well as Tirofiban and whether it increases bleeding events. This is a multicenter, randomized, controlled, single-blind Phase 4 trial involving 300 patients. Participants will be randomly assigned to receive either intracoronary rhTNK-tPA or Tirofiban. The rhTNK-tPA group receives an initial 4 mg infusion directly into the coronary artery, with a possible second 4 mg dose after 10 minutes if needed. The Tirofiban group receives a 10 μg/kg intracoronary infusion followed by an intravenous drip for at least 36 hours. The study monitors treatment effects during and after the procedures, including follow-up at 1 year. During the trial, patients undergo assessments such as measuring corrected TIMI frame count (CTFC) immediately after the intervention, TIMI flow grade, and resolution of ST-segment elevation. Heart function is evaluated at baseline and at 1, 6, and 12 months. Major adverse events like death, repeat heart attack, stroke, or hospitalizations are tracked for 1 year. Bleeding events are also monitored at various time points. The total participation spans up to 1 year for follow-up and safety monitoring.
CONDITIONS
Brief 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
- Diagnosis of ST-segment elevation myocardial infarction within 12 hours of onset
- TIMI flow grade 0-2 or TIMI thrombus grade 4 or higher after thrombus aspiration or balloon dilation
- Radial artery access available
You will not qualify if you...
- Functional coronary collateral supply (Rentrop grade 2 or higher) to the infarct-related artery
- Known or suspected old myocardial infarction of target vessels
- Rescue percutaneous coronary intervention
- Cardiogenic shock
- Contraindications to Tirofiban or rhTNK-tPA
- Severe liver or kidney problems (alanine aminotransferase 5 times above normal limit; estimated glomerular filtration rate less than 30 ml/min/1.73m2, or on dialysis)
- Cardiopulmonary resuscitation lasting longer than 10 minutes
- Mechanical heart complications (ventricular septal perforation, papillary tendon rupture, or left ventricular free wall rupture)
- Severe chronic obstructive pulmonary disease or respiratory failure
- Severe infections
- Neurological disorders
- Malignant tumors or other conditions with life expectancy under 1 year
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and up to 36 hours after
Participants receive intracoronary infusion of either rhTNK-tPA or Tirofiban during the percutaneous coronary intervention procedure. Tirofiban is also administered intravenously for 36 hours or longer after the procedure.
1 procedure visit and hospital stay for at least 36 hours
Duration - 12 months
Participants are monitored for clinical outcomes including heart function, adverse events, and recovery over one year.
Visits at 1 month, 6 months, and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
You Zhang
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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