Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
ATTRACTIVE
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
1 other identifier
interventional
2,500
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedSeptember 26, 2022
September 1, 2022
3.5 years
September 8, 2022
September 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Rate of ischemic stroke and transient ischemic attack (TIA)
up to 30 days
Rate of major bleeding evens (BARC type 2, 3 and 5)
up to 30 days
Rate of key net benefit outcome
up to 1 year
Other Outcomes (9)
Rate of primary outcome at 30 days and 1 year
up to 1 year
Rate of individual components of primary outcome
up to 1 year
Rate of all-cause mortality
up to 1 year
- +6 more other outcomes
Study Arms (2)
Intrathrombus thrombolysis
ACTIVE COMPARATORIntrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI
Aspiration thrombectomy
ACTIVE COMPARATORAspiration thrombectomy during PPCI
Interventions
Intrathrombus Thrombolysis During Primary PCI
Aspiration Thrombectomy During Primary PCI
Eligibility Criteria
You may qualify if:
- 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
- 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:
- 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
- Informed consent
You may not qualify if:
- Rescue PCI after systemic thrombolysis
- Previous CABG history
- Life expectancy\<1 year
- Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
- Serious hepatic or kidney dysfunction
- Pregnancy and lactation
- Uncontrolled hypertension (\>180/100mmHg)
- Previous hemorrhagic stroke or ischemic stroke in past 3 months
- Cardiogenic shock or cardio-pulmonary resuscitation
- Informed consent cannot be obtained or follow-up cannot be completed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Related Publications (1)
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.
PMID: 37949622DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jingang Zheng, Doctor
China-Japan Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cardiology
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 26, 2022
Study Start
September 13, 2022
Primary Completion
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
September 26, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share