Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.
Am Heart J
; 242: 115-122, 2021 12.
Статья
в английский
| MEDLINE | ID: covidwho-1392113
ABSTRACT
BACKGROUND:
The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis.DESIGN:
This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria.SUMMARY:
The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.1.
Полный текст:
Имеется в наличии
Коллекция:
Международные базы данных
база данных:
MEDLINE
Основная тема:
Thrombosis
/
Factor Xa Inhibitors
/
Rivaroxaban
/
COVID-19
Тип исследования:
Когортное исследование
/
Экспериментальные исследования
/
Наблюдательное исследование
/
Прогностическое исследование
/
Рандомизированные контролируемые испытания
Темы:
Длинный Ковид
Пределы темы:
Взрослые
/
Женщины
/
Люди
/
Мужчины
Страна как тема:
Южная Америка
/
Бразилия
Язык:
английский
Журнал:
Am Heart J
Год:
2021
Тип:
Статья
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