Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Acute Coronary Syndrome
• Interventions: Procedure: Aspiration Thrombectomy During Primary PCI; Procedure: Intrathrombus Thrombolysis During Primary PCI

• Registration Number: NCT05554588
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study Start: 2022-09-13
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspiration thrombectomy	Aspiration Thrombectomy During Primary PCI	Aspiration thrombectomy during PPCI
Intrathrombus thrombolysis	Intrathrombus Thrombolysis During Primary PCI	Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of ischemic stroke and transient ischemic attack (TIA)	up to 30 days	Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days
Rate of key net benefit outcome	up to 1 year	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)
Rate of major bleeding evens (BARC type 2, 3 and 5)	up to 30 days	Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China