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Recruiting NCT05554588

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

No phase Interventional Acute Coronary Syndrome ST Elevation Myocardial Infarction Percutaneous Coronary Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrathrombus Thrombolysis During Primary PCI, Aspiration Thrombectomy During Primary PCI.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

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.

Interventions

  • Procedure Intrathrombus Thrombolysis During Primary PCI
    Intrathrombus Thrombolysis During Primary PCI
  • Procedure Aspiration Thrombectomy During Primary PCI
    Aspiration Thrombectomy During Primary PCI

Primary outcome measures

  • Rate of major adverse cardiovascular events (MACEs) [Time frame: up to 180 days]
Secondary outcome measures (3)
  • Rate of ischemic stroke and transient ischemic attack (TIA) [Time frame: up to 30 days]
  • Rate of major bleeding evens (BARC type 2, 3 and 5) [Time frame: up to 30 days]
  • Rate of key net benefit outcome [Time frame: up to 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Publications

  • 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. BM PMID 37949622

Identifiers

NCT: NCT05554588 · CSCF2021B02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗