AtorvaStatin Postpartum and Reduction of Cardiovascular risK
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: Atorvastatin 10 mg, Placebo.
- Кому может быть актуально
- Состояния в реестре: Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension. Базовые параметры: 20 лет — 50 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
- США
- 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
AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
Обзор
The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with hypertensive disorders of pregnancy, to improve cardiovascular risk score postpartum. For this, 76 individuals with hypertensive disorders of pregnancy (HDP) will be randomized to atorvastatin 10mg or placebo, which will be started in the postpartum period after cessation of breast feeding and continued for 3 months.
Подробное описание
Individuals will be followed for up to 1 year to address the following specific aims:
Specific Aim 1: To determine if among individuals diagnosed with hypertensive disorders of pregnancy (HDP), the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months, lowers cardiovascular risk, as measured by the Framingham Risk Score for Cardiovascular Disease (30 year risk, primary outcome) and cardiovascular risk prediction model (PREVENT, secondary outcome) compared with placebo; and if the benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment.
Specific Aim 2: To determine if among individuals diagnosed with HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers the frequency of metabolic syndrome, improves lipid levels, and reduces inflammatory markers compared with placebo; and if this benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment.
Вмешательства
- Препарат Atorvastatin 10 mg
Participants will be assigned to 10 mg Atorvastatin - Препарат Placebo
Participants will be assigned to identical appearing placebo
Первичные конечные точки
- The 30-year Framingham Risk Score for Cardiovascular Disease [Срок оценки: After 3 months of study treatment, up to 9 months after enrollment]
Вторичные конечные точки (12)
- Drug Use and Side Effects [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Framingham Risk Score for Cardiovascular Disease 3-6 months following medication cessation [Срок оценки: Anytime after 3-6 months of stopping to use the study drug, up to 9 months from randomization]
- PREVENT (AHA Predicting Risk of CVD Events) score [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Rates of primary care provider (PCP) visits within 9-12 months of delivery [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery]
- Waist circumference [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Fasting glucose [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Number of individuals diagnosed with metabolic syndrome [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Lipid levels [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Hypertension diagnosis & need for antihypertensive therapy [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Diabetes diagnosis & need for anti-glycemic therapy [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Systolic blood pressure [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Estimated glomerular filtration rate [Срок оценки: From randomization until 6 months after stopping to use the study drug, up to 9 months]
Критерии участия
Критерии включения
- Postpartum
- ≥ 20 years old with the ability to give informed consent
- Diagnosis of gestational hypertension, preeclampsia prior to delivery admission, or diagnosed with preeclampsia during delivery admission, as determined by clinical team using the American College of Obstetricians and Gynecologists (ACOG) criteria.
- English speaking
Критерии исключения
- Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
- Known familial hypercholesterolemia or pre-existing hyperlipidemia, specifically Low-density Lipoprotein (LDL) >190 prior to pregnancy or diagnosis of hyperlipidemia with prescription of HMG-CoA reductase inhibitor prior to delivery,
- Plan to breastfeed for >= 6 months,
- Plan for pregnancy conception in the next 6 months,
- Incarcerated individuals,
- Hypertensive diagnosis thought to be secondary to fetal condition,
- Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
- Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
- History of rhabdomyolysis or myopathy,
- Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
- History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
- Active cancer, or
- Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus
Идентификаторы
NCT: NCT06632379 · 2024H0320