Идёт набор NCT06474182

Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

Без фазы С лечением Multiple Myeloma Total Knee Replacement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood sampling, Apixaban.
Кому может быть актуально: Состояния в реестре: Multiple Myeloma, Total Knee Replacement. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of the Effects of Prophylactic Administration of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma and Patients Undergoing a Surgery for Total Knee Replacement

Обзор

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

Вмешательства

Процедура Blood sampling
Blood sampling
Препарат Apixaban
Treatment by Apixaban

Первичные конечные точки

Endogenous Thrombin potential (nM.min) [Срок оценки: 2 hours after Apixaban Treatment]

Вторичные конечные точки (5)

Apixaban concentration (ng/mL) [Срок оценки: Kinetics of 12 hours following Apixaban treatment in both groups]
Pharmacodynamics' kinetics of Endogenous Thrombin Potential [Срок оценки: Kinetics of 12 hours following Apixaban treatment in both groups]
Pharmacodynamics' kinetics of Lagtime [Срок оценки: Kinetics of 12 hours following Apixaban treatment in both groups]
Pharmacodynamics' kinetics of Time to peak [Срок оценки: Kinetics of 12 hours following Apixaban treatment in both groups]
Pharmacodynamics' kinetics of Thrombin peak [Срок оценки: Kinetics of 12 hours following Apixaban treatment in both groups]

Критерии участия

Критерии включения

Age ≥ 18 years old,
Signed informed consent,
Patient covered by a social security scheme.
Group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with Apixaban,
Group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with Apixaban.