Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI (ATTRACTIVE)

China-Japan Friendship Hospital

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Treatments: Procedure: Intrathrombus Thrombolysis During Primary PCI; Procedure: Aspiration Thrombectomy During Primary PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT05554588

CSCF2021B02

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. Referred for PPCI

3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia

4. 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

5. Informed consent

Exclusion criteria

1. Rescue PCI after systemic thrombolysis
2. Previous CABG history
3. Life expectancy<1 year
4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
5. Serious hepatic or kidney dysfunction
6. Pregnancy and lactation
7. Uncontrolled hypertension (>180/100mmHg)
8. Previous hemorrhagic stroke or ischemic stroke in past 3 months
9. Cardiogenic shock or cardio-pulmonary resuscitation
10. Informed consent cannot be obtained or follow-up cannot be completed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

Intrathrombus thrombolysis

Active Comparator group

Description:

Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI

Treatment:

Procedure: Intrathrombus Thrombolysis During Primary PCI

Aspiration thrombectomy

Active Comparator group

Description:

Aspiration thrombectomy during PPCI

Treatment:

Procedure: Aspiration Thrombectomy During Primary PCI