AtorvaStatin Postpartum and Reduction of Cardiovascular risK

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension

In brief

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.

Key facts

Study ID

NCT06632379

Run by

Ohio State University

People needed

76

Starts

2025-10-03

Expected to finish

2026-12-15

Last updated by the study team

2025-10-20

Who can join

Age: 20 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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