NCT06769256 Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
| NCT ID | NCT06769256 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Henan Institute of Cardiovascular Epidemiology |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06769256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06769256 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06769256 currently recruiting?
Yes, NCT06769256 is actively recruiting participants. Contact the research team at 13598019682@126.com for enrollment information.
Where is the NCT06769256 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06769256 clinical trial?
NCT06769256 is sponsored by Henan Institute of Cardiovascular Epidemiology. The trial plans to enroll 300 participants.