Acute Coronary Syndrome, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
Conditions
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.
Interventions
PROCEDUREIntrathrombus Thrombolysis During Primary PCI
Intrathrombus Thrombolysis During Primary PCI
PROCEDUREAspiration Thrombectomy During Primary PCI
Aspiration Thrombectomy During Primary PCI
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ST-segment resolution above 70% | up to 30 days | Percentage of ST-segment resolution above 70% |
| Percentage of TIMI flow grade 3 | up to 30 days | Percentage of TIMI flow grade 3 |
| Rate of primary outcome at 30 days and 1 year | up to 1 year | Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization at 30 days and 1 year |
| Incidence of distal embolism | up to 30 days | Incidence of distal embolism |
| Rate of target vessel dissection | up to 30 days | Rate of target vessel dissection assessed by coronary angiography |
| Incidence of side branch occlusion | up to 30 days | Incidence of side branch occlusion |
| Rate of individual components of primary outcome | up to 1 year | Rate of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization assessed separately at 30 days, 180 days and 1 year |
| Rate of all-cause mortality | up to 1 year | Rate of all-cause mortality |
| Percentage of myocardial blush grade(MBG) of 0 or 1 | up to 30 days | Percentage of MBG 0 or 1 |
Countries
China
Contacts
Primary ContactZhen Zhang, Doctor
Backup ContactZhaoxue Sheng, Doctor
Outcome results
None listed