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

NCT ID: NCT06769256

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intracoronary rhTNK-tPA

Group Type: EXPERIMENTAL

rhTNK-tPA, 4-8 mg

Intervention Type: 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 Tirofiban

Group Type: ACTIVE_COMPARATOR

Tirofiban

Intervention Type: 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

Interventions

rhTNK-tPA, 4-8 mg

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.

Intervention Type: DRUG

Tirofiban

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Institute of Cardiovascular Epidemiology

OTHER

Sponsor Role: lead

Responsible Party

Chuanyu Gao

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

You Zhang

Role: CONTACT

13598019682@126.com

+86 37158681037

Facility Contacts

You Zhang

Role: primary

+8637158681037

Other Identifiers

HenanICE202412

Identifier Type: -

Identifier Source: org_study_id