Clinical trial NCT06632379: AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Official title: AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hypertensive Disorders of Pregnancy
Preeclampsia
Gestational Hypertension
Keywords: Hypertensive disorders of pregnancy
Atorvastatin treatment
Pregnancy
Preeclampsia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 76
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a double-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. At least 24 hours after delivery
2. ≥ 20 years old with the ability to give informed consent
3. 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.
4. English speaking

Exclusion Criteria:

1. Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
2. 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,
3. Plan to breastfeed for \>= 6 months,
4. Plan for pregnancy conception in the next 6 months,
5. Incarcerated individuals,
6. Hypertensive diagnosis thought to be secondary to fetal condition,
7. Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
8. Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
9. History of rhabdomyolysis or myopathy,
10. Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
11. History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
12. Active cancer, or
13. Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.

Primary outcomes:
measure: The 30-year Framingham Risk Score for Cardiovascular Disease
timeFrame: After 3 months of study treatment, up to 9 months after enrollment
Secondary outcomes:
measure: Drug Use and Side Effects
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Framingham Risk Score for Cardiovascular Disease 3-6 months following medication cessation
timeFrame: Anytime after 3-6 months of stopping to use the study drug, up to 9 months from randomization
measure: PREVENT (AHA Predicting Risk of CVD Events) score
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Rates of primary care provider (PCP) visits within 9-12 months of delivery
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery
measure: Waist circumference
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Fasting glucose
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Number of individuals diagnosed with metabolic syndrome
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Lipid levels
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Hypertension diagnosis & need for antihypertensive therapy
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Diabetes diagnosis & need for anti-glycemic therapy
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Systolic blood pressure
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Estimated glomerular filtration rate
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: High-sensitivity C-reactive protein (Hs-CRP) level
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Lipoprotein (a) level
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
measure: Apolipoprotein (b) level
timeFrame: From randomization until 6 months after stopping to use the study drug, up to 9 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tracy C Bank, MD
role: PRINCIPAL_INVESTIGATOR
References: