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

NCT06769256 | Recruiting Phase 4

• 1 other identifier: HenanICE202412
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (1)

• Corrected TIMI frame count (CTFC)

  At the end of Percutaneous Coronary Intervention procedure

Secondary Outcomes (5)

• 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

Study Arms (2)

Intracoronary rhTNK-tPA

EXPERIMENTAL

Drug: rhTNK-tPA, 4-8 mg

Intracoronary Tirofiban

ACTIVE COMPARATOR

Drug: Tirofiban

Interventions

rhTNK-tPA, 4-8 mg DRUG

Intracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced.

Intracoronary rhTNK-tPA

Tirofiban DRUG

Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer

Intracoronary Tirofiban

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

You Zhang

CONTACT

+86 37158681037; 13598019682@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (1)