Comparing Intracoronary Recombinant Human TNK-tPA and Tirofiban for Treating Heart Attack Patients with High Blood Clot Levels

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 gkg 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.

Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden