Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction

Официальное название

RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)

Обзор

The optimal anticoagulant for the treatment of left ventricular (LV) thrombus following acute myocardial infarction (AMI) is unclear. The aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.

Вмешательства

• Препарат Apixaban
  5 mg tablet twice a daily with dose reduction according to label
• Препарат Warfarin
  2.5 mg tablet once daily, with individual dosing according to coagulation tests

Первичные конечные точки

• Number and proportion of participants with thrombus resolution at 3 months [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Clinically relevant bleeding at 3 and 12 months [Срок оценки: 3 and 12 months]
• Severe bleeding at 3 and 12 months [Срок оценки: 3 and 12 months]
• Separate bleeding outcomes at 3 and 12 months [Срок оценки: 3 and 12 months]
• Major adverse cardiovascular outcomes (MACE) at 3 and 12 months [Срок оценки: 3 and 12 months]
• Stroke or systemic embolism at 3 and 12 months [Срок оценки: 3 and 12 months]
• LV thrombus status at 12 months [Срок оценки: 12 months]
• Net adverse clinical outcomes [Срок оценки: 3 and 12 months]

Критерии участия

Критерии включения

• Age ≥ 18 years at the time of signing the informed consent
• LV thrombus confirmed on TTE\* day 1-28 after the AMI
• Signed informed consent
• Criteria applicable only for female subjects: Women of childbearing potential must provide a negative pregnancy test not be breastfeeding and be willing and able to use highly effective contraception. Women of non-childbearing potential must be 1 year post-menopausal.

Критерии исключения

• Ongoing\* treatment with anticoagulant therapy due to Mechanical heart valve prosthesis Atrial fibrillation with or without significant mitral valve stenosis Venous thromboembolism requiring anticoagulant therapy Thrombophilia requiring anticoagulant therapy Preexisting LV thrombus already treated with anticoagulant therapy Other reasons for anticoagulant therapy
• High bleeding risk Active non-trivial bleeding Known chronic bleeding disorder Severe anemia defined as hemoglobin < 80g/L Thrombocytopenia defined as platelet count < 80 x 10\^9
• Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as Child-Pugh C or D at randomization
• Known allergy, intolerance or hypersensitivity to either of the study interventions
• Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban or warfarin.
• Participation in other study investigating effects and safety of anticoagulant treatment.
• Known current alcohol or drug abuse
• Any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study or life expectancy < 6 months

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

Швеция · 16 центров

• Falu lasarett — Falun
• Sahlgrenska University hospital, Mölndal — Gothenburg
• Sahlgrenska University hospital, Östra — Gothenburg
• Sahlgrenska University hospital — Gothenburg
• Linköping University hospital — Linköping
• Skånes Universitetssjukhus Lund — Lund
• Skånes University hospital, Malmö — Malmö
• Vrinnevi hospital — Nörrköping
• … и ещё 8 центров

Идентификаторы

NCT: NCT06515730 · RESOLVE-AMI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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