Acute Coronary Syndrome Clinical Trial
— ATTRACTIVEOfficial title:
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
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).
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | September 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China-Japan Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of primary outcome at 30 days and 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 | up to 1 year | |
Other | Rate of individual components of primary outcome | 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 | up to 1 year | |
Other | Rate of all-cause mortality | Rate of all-cause mortality | up to 1 year | |
Other | Percentage of myocardial blush grade(MBG) of 0 or 1 | Percentage of MBG 0 or 1 | up to 30 days | |
Other | Percentage of ST-segment resolution above 70% | Percentage of ST-segment resolution above 70% | up to 30 days | |
Other | Percentage of TIMI flow grade 3 | Percentage of TIMI flow grade 3 | up to 30 days | |
Other | Incidence of side branch occlusion | Incidence of side branch occlusion | up to 30 days | |
Other | Incidence of distal embolism | Incidence of distal embolism | up to 30 days | |
Other | Rate of target vessel dissection | Rate of target vessel dissection assessed by coronary angiography | up to 30 days | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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