Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Study Overview
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Brief Summary
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This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).

Detailed Description
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The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.

Official Title
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A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden

Conditions
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Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Intrathrombus Thrombolysis During Primary PCI
* Procedure: Aspiration Thrombectomy During Primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with: Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads Referred for PPCI Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia High thrombus burden: TIMI thrombus grade 3 or 4 after emergency coronary angiography Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5 Informed consent Exclusion Criteria: Rescue PCI after systemic thrombolysis Previous CABG history Life expectancy<1 year Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding Serious hepatic or kidney dysfunction Pregnancy and lactation Uncontrolled hypertension (>180/100mmHg) Previous hemorrhagic stroke or ischemic stroke in past 3 months Cardiogenic shock or cardio-pulmonary resuscitation Informed consent cannot be obtained or follow-up cannot be completed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathrombus thrombolysis<br>Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI | Procedure: Intrathrombus Thrombolysis During Primary PCI<br>* Intrathrombus Thrombolysis During Primary PCI<br>|
| Active Comparator: Aspiration thrombectomy<br>Aspiration thrombectomy during PPCI | Procedure: Aspiration Thrombectomy During Primary PCI<br>* Aspiration Thrombectomy During Primary PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse cardiovascular events (MACEs) | Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization | up to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ischemic stroke and transient ischemic attack (TIA) | Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days | up to 30 days | 
| Rate of major bleeding evens (BARC type 2, 3 and 5) | Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days | up to 30 days | 
| Rate of key net benefit outcome | cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis, target-vessel revascularization, stroke and major bleeding evens (BARC 2,3 and 5) | up to 1 year |