AtorvaStatin Postpartum and Reduction of Cardiovascular risK

NCT06632379 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024H0320
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertensive disorders of pregnancy; Atorvastatin treatment; Pregnancy; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• The 30-year Framingham Risk Score for Cardiovascular Disease

  Predicts 0-100% risk of "hard" CVD events (coronary death, myocardial infarction, stroke) based on sex, systolic blood pressure, antihypertensive treatment, total and high-density lipoprotein cholesterol, smoking, and diabetes mellitus. A higher number reflects a greater risk of adverse CVD events, whereas a lower number reflects lower risk.

  After 3 months of study treatment, up to 9 months after enrollment

Secondary Outcomes (15)

• Drug Use and Side Effects

  From randomization until 6 months after stopping to use the study drug, up to 9 months

• Framingham Risk Score for Cardiovascular Disease 3-6 months following medication cessation

  Anytime after 3-6 months of stopping to use the study drug, up to 9 months from randomization

• PREVENT (AHA Predicting Risk of CVD Events) score

  From randomization until 6 months after stopping to use the study drug, up to 9 months

• Rates of primary care provider (PCP) visits within 9-12 months of delivery

  From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery

• Waist circumference

  From randomization until 6 months after stopping to use the study drug, up to 9 months

Study Arms (2)

10 mg Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 10 mg daily for 3 months

Drug: Atorvastatin 10 mg

Placebo

PLACEBO COMPARATOR

Identical appearing placebo for 3 months

Drug: Placebo

Interventions

Atorvastatin 10 mg DRUG

Participants will be assigned to 10 mg Atorvastatin

10 mg Atorvastatin

Placebo DRUG

Participants will be assigned to identical appearing placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Tracy C Bank, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy C Bank, MD

CONTACT

614-293-2222; Tracy.Bank@osumc.edu

Maged Costantine, MD, MBA

CONTACT

614-293-2222; Maged.Costantine@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD (Fellow)

Model Details: a double-blinded randomized controlled trial

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 9, 2024
• Study Start: October 3, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)