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

Launched by HENAN INSTITUTE OF CARDIOVASCULAR EPIDEMIOLOGY · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to compare two treatments for patients who are experiencing a type of heart attack called ST-segment elevation myocardial infarction (STEMI). The researchers want to find out if a medication called rhTNK-tPA is as effective as another medication, Tirofiban, in helping patients with a high amount of blood clots in their arteries. They are also checking if rhTNK-tPA causes more bleeding compared to Tirofiban. The study will involve 300 patients who will be randomly assigned to receive one of the two treatments, and they will be monitored for up to a year for any serious health issues.

To be eligible for this trial, participants need to be between 18 and 75 years old and must be experiencing a STEMI within 12 hours of the start of their symptoms. Other criteria include having a certain level of blood flow in the heart arteries and using a specific access point in the wrist for treatment. The trial is not yet recruiting participants, but it’s important for those who might be interested to know that there are several health conditions that could exclude someone from participating. Overall, this study aims to provide important information about the best treatment options for patients with this serious heart condition.

Gender

ALL

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