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Идёт набор NCT06603870

Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

Фаза IV С лечением Venous Thromboembolism Cancer Upper Extremity Deep Vein Thrombosis Catheter-Related Infections

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: Apixaban.
Кому может быть актуально
Состояния в реестре: Venous Thromboembolism, Cancer, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections. 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
Канада
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

Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)

Обзор

This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).

Подробное описание

The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.

Вмешательства

  • Препарат Apixaban
    Apixaban is Health Canada approved for routine treatment and secondary prevention of VTE. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a CVC or active cancer is present. Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Patients will be instructed to contact the study team when their CVC is removed (to determine if apixaban should be continued, based on cancer s

Первичные конечные точки

  • Venous Thromboembolism (VTE) Rate [Срок оценки: 6 months]
Вторичные конечные точки (11)
  • Major Venous Thromboembolism (VTE) and Major bleeding Rate [Срок оценки: 3 months]
  • New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT). [Срок оценки: 3 months and 6 months]
  • New incidental Venous Thromboembolism (VTE) [Срок оценки: 3 months and 6 months]
  • New Deep Vein Thrombosis (DVT) [Срок оценки: 3 months and 6 months]
  • Superficial vein thrombosis of upper or lower extremities [Срок оценки: 3 months and 6 months]
  • New unusual site Venous Thromboembolism (VTE) [Срок оценки: 3 months and 6 months]
  • Clinically Relevant Non-Major Bleeding (CRNMB) events [Срок оценки: 3 months and 6 months]
  • Arterial thromboembolic events [Срок оценки: 3 months and 6 months]
  • All-cause mortality [Срок оценки: 3 months and 6 months]
  • Correlative biomarkers [Срок оценки: 6 months]
  • Health-related quality of life using the EuroQoL-5D-5L Questionnaire [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
  • Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
  • Able and willing to provide informed consent.

Критерии исключения

  • Active bleeding or other reasons for which anticoagulation is contraindicated.
  • Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
  • Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .
  • Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.
  • Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • The Ottawa Hospital — Ottawa

Идентификаторы

NCT: NCT06603870 · STREAM-Line

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗