Clinical trial NCT06654453: The Thrombus Aspiration During PCI After Thrombolysis in STEMI
Official title: The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: ST-segment elevation myocardial infarction
Thrombus aspiration
Percutaneous coronary intervention
High thrombus burden
Randomized controlled trial
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 30-day Major Adverse Cardiovascular Events (MACE)
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Reperfusion Success
timeFrame: Within 30 minutes post-PCI (Percutaneous Coronary Intervention)
measure: Follow-up MACE at 6 Months
timeFrame: From enrollment to the end of treatment at 6 months
measure: Follow-up all-cause mortality at 6 Months
timeFrame: From enrollment to the end of treatment at 6 months
measure: Follow-up MACE at 12 Months
timeFrame: From enrollment to the end of treatment at 12 months
measure: Follow-up all-cause mortality at 12 Months
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
Study officials:
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