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: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fuwai Central China Cardiovascular Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
You Zhang
13598019682@126.com
+86 37158681037
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 300
Treatments
Experimental: Intracoronary rhTNK-tPA
Active_comparator: Intracoronary Tirofiban
Related Therapeutic Areas
Sponsors
Leads: Henan Institute of Cardiovascular Epidemiology

This content was sourced from clinicaltrials.gov

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