Thrombus Aspiration in STEMI Patients With High Thrombus Burden

Официальное название

Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

Обзор

This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.

Подробное описание

This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

Вмешательства

• Процедура Thrombus aspiration
  Percutaneous Coronary Intervention with manual aspiration thrombectomy
• Процедура PCI Alone
  Percutaneous Coronary Intervention without manual aspiration thrombectomy

Первичные конечные точки

• Major adverse cardiovascular events [Срок оценки: up to180 days]

Вторичные конечные точки (2)

• Stroke [Срок оценки: up to 30 days]
• Composite adverse cardiocerebrovascular events [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
• High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
• Informed consent must be voluntary;

Критерии исключения

• Haemodynamic instability or cardiogenic shock;
• After thrombolytic therapy;
• The predicted survival time is less than 6 months due to non-cardiac disease;
• History of coronary artery bypass grafting;
• Participate in other researches within 30 days;
• Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
• Patients were considered unsuitable by other researchers.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 50 центров

• Fujian Provincial Hospital — Фучжоу
• First People's Hospital of Foshan — Foshan
• The Second People's Hospital of Nanhai District — Foshan
• First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical Univers — Foshan
• Guangdong Provincial People's Hospital — Гуанчжоу
• Guangzhou Panyu Central Hospital — Гуанчжоу
• Guangzhou General Hospital of Guangzhou Military Command — Гуанчжоу
• The first Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу
• … и ещё 42 центра

Публикации

• Herrick JB. Landmark article (JAMA 1912). Clinical features of sudden obstruction of the coronary arteries. By James B. Herrick. JAMA. 1983 Oct 7;250(13):1757-65. No abstract available. PMID 6350634
• DeWood MA, Spores J, Notske R, Mouser LT, Burroughs R, Golden MS, Lang HT. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. N Engl J Med. 1980 Oct 16;303(16):897-902. doi: 10.1056/NEJM198010163031601. PMID 7412821
• Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30. PMID 17692740
• Beran G, Lang I, Schreiber W, Denk S, Stefenelli T, Syeda B, Maurer G, Glogar D, Siostrzonek P. Intracoronary thrombectomy with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome: a prospective, randomized, controlled study. Circulation. 2002 May 21;105(20):2355-60. doi: 10.1161/01.cir.0000016350.02669.1d. PMID 12021220
• Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 200 PMID 16022970
• Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-673 PMID 18539223
• Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa PMID 23991656
• Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primar PMID 25853743

Идентификаторы

NCT: NCT04212494 · GDREC2018404H(R2)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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