The Thrombus Aspiration During PCI After Thrombolysis in STEMI

NCT ID: NCT06654453

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-11-01

Brief Summary

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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

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Conditions

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ST-segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Thrombectomy + PCI Arm

This group will receive thrombectomy combined with percutaneous coronary intervention.

Group Type EXPERIMENTAL

Thrombectomy

Intervention Type 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

Intervention Type PROCEDURE

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

PCI-only Arm

PCI is an established treatment for STEMI, and you are comparing it to the experimental group that receives an additional thrombectomy procedure.

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

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

Interventions

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Thrombectomy

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

Intervention Type PROCEDURE

Percutaneous Coronary Intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenghua Zhou

OTHER

Sponsor Role lead

Responsible Party

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Shenghua Zhou

Director

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Shenghua Zhou

Role: CONTACT

073185292012

Other Identifiers

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KYZ20240204

Identifier Type: -

Identifier Source: org_study_id

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