Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Rate of major adverse cardiovascular events (MACEs) [Срок оценки: up to 180 days]

Вторичные конечные точки (3)

• Rate of ischemic stroke and transient ischemic attack (TIA) [Срок оценки: up to 30 days]
• Rate of major bleeding evens (BARC type 2, 3 and 5) [Срок оценки: up to 30 days]
• Rate of key net benefit outcome [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT05554588 · CSCF2021B02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗