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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathrombus thrombolysis | Active Comparator | Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI |
|
| Aspiration thrombectomy | Active Comparator | Aspiration thrombectomy during PPCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathrombus Thrombolysis During Primary PCI | Procedure | Intrathrombus Thrombolysis During Primary PCI |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of individual components of primary outcome |
Inclusion Criteria:
Patients presenting with:
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:
Informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Zhang, Doctor | Contact | +86 15210849352 | bjmuzz@163.com | |
| Zhaoxue Sheng, Doctor | Contact | +86 15600268925 | shengzhaoxue@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingang Zheng, Doctor | China-Japan Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37949622 | Derived | Zhang Z, Sheng Z, Che W, An S, Sun D, Zhai Z, Zhao X, Yang Y, Meng Z, Ye Z, Xie E, Li P, Yu C, Gao Y, Xiao Z, Wu Y, Dong F, Ren J, Zheng J. Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden. BMJ Open. 2023 Nov 10;13(11):e076476. doi: 10.1136/bmjopen-2023-076476. |
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| Aspiration Thrombectomy During Primary PCI | Procedure | Aspiration Thrombectomy During Primary PCI |
|
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 |
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 |
| Rate of all-cause mortality | Rate of all-cause mortality | up to 1 year |
| Percentage of myocardial blush grade(MBG) of 0 or 1 | Percentage of MBG 0 or 1 | up to 30 days |
| Percentage of ST-segment resolution above 70% | Percentage of ST-segment resolution above 70% | up to 30 days |
| Percentage of TIMI flow grade 3 | Percentage of TIMI flow grade 3 | up to 30 days |
| Incidence of side branch occlusion | Incidence of side branch occlusion | up to 30 days |
| Incidence of distal embolism | Incidence of distal embolism | up to 30 days |
| Rate of target vessel dissection | Rate of target vessel dissection assessed by coronary angiography | up to 30 days |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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