Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

Обзор

The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.

Вмешательства

• Препарат Ticagrelor
  Ticagrelor monotherapy for 12 months
• Препарат Aspirin
  Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Первичные конечные точки

• Composite of major adverse cardiac and cerebral events (MACCE) [Срок оценки: 1, 3 and 13 months after primary PCI]
• Intramyocardial haemorrhage (IMH) [Срок оценки: day 5-8 post primary PCI]

Вторичные конечные точки (3)

• Bleeding complications [Срок оценки: 1, 3 and 13 months after primary PCI]
• All-cause mortality [Срок оценки: 1, 3 and 13 months after primary PCI]
• Platelet reactivity [Срок оценки: 5-8 days]

Критерии участия

Критерии включения

• Clinical and electrocardiographical diagnosis of STEMI
• Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)

Критерии исключения

• Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
• Previous PCI or MI less than 12 months ago
• Previous cardiac surgery
• Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
• Pregnancy and breast feeding
• Concurrent use of oral anticoagulants (OAC)
• The periprocedural use of GPIIb/IIIa inhibitors
• Planned surgical intervention within 12 months of PCI
• Creatinine clearance <30mL/min or dialysis
• PCI of stent thrombosis
• Suboptimal stent result as judged by the interventional cardiologist.
• Life expectancy shorter than 13 months.
• Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).

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

Нидерланды · 5 центров

• Noordwest Ziekenhuisgroep Alkmaar — Alkmaar
• Amsterdam UMC — Amsterdam
• Rijnstate — Arnhem
• Medisch Spectrum Twente — Enschede
• Radboudumc — Nijmegen

Публикации

• Yosofi B, Woelders ECI, Peeters DAM, von Birgelen C, van Rees JB, Heestermans AACM, Claessen BEPM, van den Oord SCH, Dirksen MT, van Vliet D, Konijnenberg LSF, Cetinyurek-Yavuz A, van Royen N, van Geuns RM, Nijveldt R, Damman P. Ticagrelor monotherapy versus dual antiplatelet therapy after primary percutaneous coronary intervention: one-year outcomes of the pilot STOP-IMH randomised trial. EuroInt PMID 42200636

Идентификаторы

NCT: NCT05986968 · NL82646.091.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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