AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The 30-year Framingham Risk Score for Cardiovascular Disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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.
研究组 & 干预措施
10 mg Atorvastatin
Atorvastatin 10 mg daily for 3 months
干预措施: Atorvastatin 10 mg (Drug)
Placebo
Identical appearing placebo for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
The 30-year Framingham Risk Score for Cardiovascular Disease
时间窗: After 3 months of study treatment, up to 9 months after enrollment
Predicts 0-100% risk of "hard" CVD events (coronary death, myocardial infarction, stroke) based on sex, systolic blood pressure, antihypertensive treatment, total and high-density lipoprotein cholesterol, smoking, and diabetes mellitus. A higher number reflects a greater risk of adverse CVD events, whereas a lower number reflects lower risk.
次要结局
- Apolipoprotein (b) level(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Drug Use and Side Effects(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(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(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(From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery)
- Waist circumference(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Fasting glucose(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Number of individuals diagnosed with metabolic syndrome(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Lipid levels(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Hypertension diagnosis & need for antihypertensive therapy(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Diabetes diagnosis & need for anti-glycemic therapy(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Systolic blood pressure(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Estimated glomerular filtration rate(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- High-sensitivity C-reactive protein (Hs-CRP) level(From randomization until 6 months after stopping to use the study drug, up to 9 months)
- Lipoprotein (a) level(From randomization until 6 months after stopping to use the study drug, up to 9 months)
研究者
Tracy Caroline Bank
MD (Fellow)
Ohio State University