Recruiting

Atorvastatin

Sponsor:

Ohio State University

Code:

NCT06632379

Conditions

Hypertensive Disorders of Pregnancy

Preeclampsia

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Not accepted

Interventions

Atorvastatin 10 mg

Placebo

Study Details

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.

Conditions

Hypertensive Disorders of Pregnancy

Preeclampsia

Gestational Hypertension

Study ID

NCT06632379

Start date

Oct 3, 2025

Status verified date

Oct, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Not accepted

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. 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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 10 mg Atorvastatin

Atorvastatin 10 mg daily for 3 months

placebo comparator: Placebo

Identical appearing placebo for 3 months

Interventions

Atorvastatin 10 mg

Participants will be assigned to 10 mg Atorvastatin

Placebo

Participants will be assigned to identical appearing placebo

Primary outcome measure

  • The 30-year Framingham Risk Score for Cardiovascular Disease [ Time Frame: After 3 months of study treatment, up to 9 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Kara Rood, MD

More Information

Sponsor

Ohio State University

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Hypertensive disorders of pregnancy
  • Atorvastatin treatment
  • Pregnancy
  • Preeclampsia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-10-20.