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

Phase 4

Not yet recruiting

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Interventions: Drug: rhTNK-tPA, 4-8 mg; Drug: Tirofiban

• Registration Number: NCT06769256
• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-26
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

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Exclusion Criteria

• A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated 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 ≥5 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary rhTNK-tPA	rhTNK-tPA, 4-8 mg	-
Intracoronary Tirofiban	Tirofiban	-

Primary Outcome Measures

Name	Time	Method
Corrected TIMI frame count (CTFC)	At the end of Percutaneous Coronary Intervention procedure

Secondary Outcome Measures

Name	Time	Method
TIMI flow grade	At the end of Percutaneous Coronary Intervention procedure
Complete ST-segment resolution (STR)	1 hour post PCI procedure
Left ventricular ejection fraction (LVEF)	Baseline, 1 month, 6 months and 12 months
A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure	1 month, 6 months and 12 months
Bleeding events according to the BARC bleeding classification	At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months