Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
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.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2027-12-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenecteplase | Protein / enzyme biologic | 4 mg | — |
| Comparator | Tirofiban | Other / unclassified | 0.075 ug/kg | Intravenous |
| Comparator | Tirofiban | Other / unclassified | 0.15 ug/kg | Intravenous |