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NCT Number: NCT06654453

The Thrombus Aspiration During PCI After Thrombolysis in STEMI

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.

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Key information

Conditions

ST-segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

Thrombectomy

Procedure

Manual thrombectomy followed by Percutaneous Coronary Intervention (PCI), a procedure involving mechanical removal of thrombus before stent placement in coronary arteries to restore blood flow in STEM

Percutaneous coronary intervention

Procedure

Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.

Primary outcomes

  1. 30-day Major Adverse Cardiovascular Events (MACE)

    Time frame: 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 outcomes

  1. Reperfusion Success

    Time frame: 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.

  2. Follow-up MACE at 6 Months

    Time frame: 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.

  3. Follow-up all-cause mortality at 6 Months

    Time frame: From enrollment to the end of treatment at 6 months

    The rate of all-cause mortality occurring within 6 months post-intervention.

  4. Follow-up MACE at 12 Months

    Time frame: 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.

  5. Follow-up all-cause mortality at 12 Months

    Time frame: From enrollment to the end of treatment at 12 months

    The rate of all-cause mortality occurring within 12 months post-intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Shenghua Zhou

CONTACT

[email protected]

073185292012

Sponsors and collaborators

Lead sponsor

Shenghua Zhou

Other

Registry information

Official study title

The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction

Acronym: Optimal

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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