AtorvaStatin Postpartum and Reduction of Cardiovascular risK

NCT ID: NCT06632379

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-03
• Study Completion Date: 2026-12-15

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.

Conditions

Hypertensive Disorders of Pregnancy; Preeclampsia; Gestational Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg Atorvastatin

Atorvastatin 10 mg daily for 3 months

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10 mg

Intervention Type: DRUG

Participants will be assigned to 10 mg Atorvastatin

Placebo

Identical appearing placebo for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will be assigned to identical appearing placebo

Interventions

Atorvastatin 10 mg

Participants will be assigned to 10 mg Atorvastatin

Intervention Type: DRUG

Placebo

Participants will be assigned to identical appearing placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Tracy Caroline Bank

MD (Fellow)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy C Bank, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracy C Bank, MD

Role: CONTACT

Tracy.Bank@osumc.edu

614-293-2222

Maged Costantine, MD, MBA

Role: CONTACT

Maged.Costantine@osumc.edu

614-293-2222

Facility Contacts

Maged Costantine, MD, MBA

Role: primary

Maged.Costantine@osumc.edu

614-293-2222

Kara Rood, MD

Role: backup

Kara.Rood@osumc.edu

614-293-8045

Other Identifiers

2024H0320

Identifier Type: -

Identifier Source: org_study_id