The Thrombus Aspiration During PCI After Thrombolysis in STEMI

Recruiting now · Not applicable

Conditions studied: ST-segment Elevation Myocardial Infarction

In brief

The goal of this clinical trial is to determine whether thrombus aspiration combined with percutaneous coronary intervention (PCI) improves clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients with high thrombus burden post-thrombolysis, compared to PCI alone. The study population includes 3500 STEMI patients, confirmed by diagnosis, who are transferred to PCI centers after receiving thrombolysis and have no contraindications to thrombolysis.The main questions it aims to answer are: 1. Does thrombus aspiration reduce 30-day major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, stroke, or heart failure rehospitalization? 2. Can thrombus aspiration improve microcirculation and clinical outcomes for high thrombus burden patients after thrombolysis? Researchers will compare patients randomly assigned to receive thrombus aspiration combined with PCI versus those who receive PCI alone to evaluate the effects on reducing MACE and improving clinical recovery. Participants will: Undergo initial thrombolysis followed by transfer to PCI centers. Be randomly assigned in a 1:1 ratio to receive either thrombus aspiration combined with PCI or PCI alone. Be followed for 30 days post-treatment to assess MACE and other clinical outcomes.

Key facts

Study ID

NCT06654453

Run by

Shenghua Zhou

People needed

3500

Starts

2024-11-01

Expected to finish

2028-11-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with STEMI.
• No contraindications for thrombolysis and has received thrombolytic treatment.
• Undergoing coronary angiography within 2 to 24 hours post-thrombolysis.
• Angiographic results confirm TIMI thrombus load ≥ 4 and residual stenosis > 50%.

You may not qualify if…

• Contraindications for thrombolysis.
• Cardiogenic shock.
• Need for coronary artery bypass grafting.
• Age less than 18 years.
• Life expectancy of less than 6 months.
• Unable to provide informed consent.

Where it is running

• Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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