Atorvastatin after pregnancy to lower future heart disease risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial enrolling 76 postpartum individuals with hypertensive disorders of pregnancy who have stopped breastfeeding. Participants are randomized to atorvastatin 10 mg daily or matching placebo for three months and are followed for up to one year. The primary outcome is change in the Framingham 30-year cardiovascular risk score, with secondary outcomes including the PREVENT risk model, metabolic syndrome frequency, lipid levels, and inflammatory markers. The study will also assess whether any benefits persist 3–6 months after stopping the study medication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Postpartum
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. Breastfeeding 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.

Where it's running

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Tracy C Bank, MD — Ohio State University
• Study coordinator: Tracy C Bank, MD
• Email: Tracy.Bank@osumc.edu
• Phone: 614-293-2222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.