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Идёт набор NCT05646394

Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS

— Наблюдательное Antiphospholipid Syndrome Arterial Thrombosis

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: Dual antiplatelet therapy, Combined antithrombotic therapy, Vitamin K antagonist standard intensity, Vitamin K antagonist high intensity.
Кому может быть актуально
Состояния в реестре: Antiphospholipid Syndrome, Arterial Thrombosis. 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
Аргентина, Канада
Следующий шаг
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Обзор

The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.

Подробное описание

The optimal antithrombotic management of patients with antiphospholipid syndrome and arterial thrombotic events is unclear. The guidelines provide several options, mostly with vitamin K antagonist with/without an antiplatelet agent. Dual antiplatelet therapy (DAPT) was in a meta-analysis potentially effective, but included studies were few and small.

The primary aim is to compare a vitamin K antagonist (VKA), i.e. warfarin, acenocoumarol, phenprocoumon etc, with international normalized ratio 2.0-3.0 plus low-dose aspirin (75-100 mg) with DAPT - typically low-dose aspirin plus clopidogrel (75 mg daily) but other combinations will be acceptable. The registry will also include patients treated with VKA alone at standard- or high-intensity, since this is recommended and will serve as reference groups in comparison with VKA + low-dose aspirin and versus DAPT. The outcomes are (efficacy) arterial or venous thromboembolism, vascular death or (safety) major bleeding.

A secondary objective is to analyze how the cardiovascular risk factors (hypertension, hyperlipidemia, obesity, smoking, diabetes, and heart failure), venous thrombotic risk factors (previous venous thromboembolism, cancer, immobility, chronic inflammatory disease) and anti-phospholipid profile contribute to recurrent arterial thrombosis.

Вмешательства

  • Препарат Dual antiplatelet therapy
    Aspirin plus any of clopidogrel, ticagrelor or prasugrel
  • Препарат Combined antithrombotic therapy
    Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.
  • Препарат Vitamin K antagonist standard intensity
    vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0
  • Препарат Vitamin K antagonist high intensity
    vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0

Первичные конечные точки

  • Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise [Срок оценки: 2 years]
  • Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria [Срок оценки: 2 years]
Вторичные конечные точки (3)
  • Number of Participants with arterial thrombosis verified by diagnostic imaging [Срок оценки: 2 years]
  • Number of Participants with venous thromboembolism verified by diagnostic imaging [Срок оценки: 2 years]
  • Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients of at least 18 years of age with confirmed antiphospholipid syndrome according to Sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging.
  • Treatment with either A) a vitamin K antagonist (VKA) with therapeutic range, international normalized ratio (INR) 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0 or C) VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen, if considered appropriate by the treating physician.
  • Signed informed consent obtained (in jurisdictions where required).

Критерии исключения

  • Inability to follow the patient due to geographical or other reasons.
  • Patients with documented poor compliance.
  • Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.
  • Pregnancy or planned pregnancy.
  • Venous thrombotic event diagnosed after the last arterial event.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Аргентина · 2 центра
  • Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires — Buenos Aires
  • Clinica Universitaria Reina Fabiola — Córdoba
Канада · 1 центр
  • McMaster University — Hamilton

Идентификаторы

NCT: NCT05646394 · AATAAPS2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗