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Идёт набор NCT07742488

Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia

— Наблюдательное Menopausal Complaints Hypercholerolemia Coagulation Tests

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: estroprogestins, Statin.
Кому может быть актуально
Состояния в реестре: Menopausal Complaints, Hypercholerolemia, Coagulation Tests. Базовые параметры: 45 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study

Обзор

The goal of this study is to understand whether statin therapy, a common lipid-lowering therapy, may improve the coagulation profile of menopausal women with hypercholesterolemia undergoing hormone replacement therapy with oral estroprogestin. It will also learn about the liver safety of the combination. The main questions will be: 1. does hormone replacement therapy affect the coagulation profile? 2. when we add statin therapy due to hypercholesterolemia not improving with lifestyle, does it reverse eventual changes of the coagulation profile occurred after initiation of hormone replacement therapy? 3. do the two therapies have an effect on overall inflammation of the organism? Participants will be asked to participate to the study before starting any therapy, if they need hormone relacement therapy due to symptoms, if they have a new onset of dyslipidemia and if they do not have contraindications to the therapies object of the study. The study is observational, thus it will not affect in any way the clinical care, which will follow only guidelines. During routine blood sample collection, additional aliquotes will be taken for the study at the recruitment, after 3 months of hormone replacement therapy and lifestyle changes, at the end of the study (after one year from the recruitment).

Вмешательства

  • Препарат estroprogestins
    To be included in the study, patients must have menopausal symptoms requiring hormone replacement therapy without contraindications to it. All cohorts will undergo this therapy.
  • Препарат Statin
    After 3 months, patients not controlling hypercholesterolemia with lifestyle changes will be prescribed statin as per clinical routine practice. They will be part of the HRT+statin cohort.

Первичные конечные точки

  • HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay [Срок оценки: From 3 months to end of study (12 months)]
Вторичные конечные точки (4)
  • HRT+Statin vs HRT only on the nAPCsr after TGA [Срок оценки: From 3 months to end of study (12 months)]
  • HRT+statins vs HRT only do not increase liver transaminases [Срок оценки: From 3 months to end of study (12 months)]
  • HRT+statins vs HRT only on coagulation factors [Срок оценки: From 3 months to end of study (12 months)]
  • HRT+statins vs HRT only on inflammatory markers [Срок оценки: From 3 months to end of study (12 months)]

Критерии участия

Критерии включения

  • Women aged between 45 and 55
  • Early postmenopausal period (within 5 years of the last menstrual cycle).
  • Prescription of oral estrogen-progestin HRT for symptoms that require it according to current guidelines
  • Low-moderate cardiovascular risk (SCORE2 calculation and assessment based on age)
  • LDL levels above target according to the class of risk

Критерии исключения

  • Recent pregnancy (<1 year) or current breastfeeding
  • Ongoing therapies that interfere with the study objectives: HRT or other estroprogestin therapy, lipid-lowering drugs, anticoagulants, or antiplatelet agents
  • Current or previous venous or arterial thrombotic event
  • Diagnosis of cancer for which treatment is ongoing or has been discontinued for less than 10 years
  • Known hereditary thrombophilia
  • Chronic inflammatory bowel disease
  • Diabetes mellitus
  • Body mass index (BMI) > 30 kg/m²
  • Acute/chronic liver failure or abnormal liver enzymes (ALT or AST > 100 IU/L; GGT > 100 IU/L; alkaline phosphatase > 250 IU/L)
  • Other known risk factors for VTE or contraindications to HRT
  • Refusal to take HRT

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Santa Chiara Hospital - University Hospital of Pisa — Pisa

Идентификаторы

NCT: NCT07742488 · STAR_HRT

Первоисточники (государственные реестры)

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