The Thrombus Aspiration During PCI After Thrombolysis in STEMI

Not Applicable

Not yet recruiting

• Conditions: ST-segment Elevation Myocardial Infarction

• Registration Number: NCT06654453
• Lead Sponsor: Shenghua Zhou

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Study Start: 2024-11-01
• Primary Completion: 2028-11-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-day Major Adverse Cardiovascular Events (MACE)	From enrollment to the end of treatment at 4 weeks	A composite of cardiovascular death, recurrent myocardial infarction, stroke, and rehospitalization for heart failure within 30 days post-intervention.

Secondary Outcome Measures

Name	Time	Method
Reperfusion Success	Within 30 minutes post-PCI (Percutaneous Coronary Intervention)	The percentage of patients achieving successful reperfusion as indicated by TIMI flow grade improvement (e.g., achieving TIMI 2 or 3 flow) after the intervention.
Follow-up MACE at 6 Months	From enrollment to the end of treatment at 6 months	The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 6 months post-intervention.
Follow-up all-cause mortality at 6 Months	From enrollment to the end of treatment at 6 months	The rate of all-cause mortality occurring within 6 months post-intervention.
Follow-up MACE at 12 Months	From enrollment to the end of treatment at 12 months	The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 12 months post-intervention.
Follow-up all-cause mortality at 12 Months	From enrollment to the end of treatment at 12 months	The rate of all-cause mortality occurring within 12 months post-intervention.