AtorvaStatin Postpartum and Reduction of Cardiovascular risK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin 10 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension. Basic parameters: 20 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
Overview
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.
Detailed description
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.
Interventions
- Drug Atorvastatin 10 mg
Participants will be assigned to 10 mg Atorvastatin - Drug Placebo
Participants will be assigned to identical appearing placebo
Primary outcome measures
- The 30-year Framingham Risk Score for Cardiovascular Disease [Time frame: After 3 months of study treatment, up to 9 months after enrollment]
Secondary outcome measures (12)
- Drug Use and Side Effects [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery]
- Waist circumference [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Fasting glucose [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Number of individuals diagnosed with metabolic syndrome [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Lipid levels [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Hypertension diagnosis & need for antihypertensive therapy [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Diabetes diagnosis & need for anti-glycemic therapy [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Systolic blood pressure [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
- Estimated glomerular filtration rate [Time frame: From randomization until 6 months after stopping to use the study drug, up to 9 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus
Identifiers
NCT: NCT06632379 · 2024H0320