Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

NCT ID: NCT05554588

Last Updated: 2022-09-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2026-09-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Acute Coronary Syndrome ST Elevation Myocardial Infarction Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intrathrombus thrombolysis

Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI

Group Type ACTIVE_COMPARATOR

Intrathrombus Thrombolysis During Primary PCI

Intervention Type PROCEDURE

Intrathrombus Thrombolysis During Primary PCI

Aspiration thrombectomy

Aspiration thrombectomy during PPCI

Group Type ACTIVE_COMPARATOR

Aspiration Thrombectomy During Primary PCI

Intervention Type PROCEDURE

Aspiration Thrombectomy During Primary PCI

Interventions

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Intrathrombus Thrombolysis During Primary PCI

Intrathrombus Thrombolysis During Primary PCI

Intervention Type PROCEDURE

Aspiration Thrombectomy During Primary PCI

Aspiration Thrombectomy During Primary PCI

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingang Zheng

Director of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Zhang, Doctor

Role: CONTACT

+86 15210849352

Zhaoxue Sheng, Doctor

Role: CONTACT

+86 15600268925

Facility Contacts

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Zhen Zhang

Role: primary

+8615210849352

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.

Reference Type DERIVED
PMID: 37949622 (View on PubMed)

Other Identifiers

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CSCF2021B02

Identifier Type: -

Identifier Source: org_study_id

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