Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
NCT ID: NCT05554588
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2500 participants
INTERVENTIONAL
2022-09-13
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intrathrombus thrombolysis
Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI
Intrathrombus Thrombolysis During Primary PCI
Intrathrombus Thrombolysis During Primary PCI
Aspiration thrombectomy
Aspiration thrombectomy during PPCI
Aspiration Thrombectomy During Primary PCI
Aspiration Thrombectomy During Primary PCI
Interventions
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Intrathrombus Thrombolysis During Primary PCI
Intrathrombus Thrombolysis During Primary PCI
Aspiration Thrombectomy During Primary PCI
Aspiration Thrombectomy During Primary PCI
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
80 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Jingang Zheng
Director of Cardiology
Principal Investigators
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Jingang Zheng, Doctor
Role: STUDY_CHAIR
China-Japan Friendship Hospital
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CSCF2021B02
Identifier Type: -
Identifier Source: org_study_id
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