Actively Recruiting

Phase 4
Age: 20Years - 50Years
FEMALE
NCT06632379

AtorvaStatin Postpartum and Reduction of Cardiovascular risK

Led by Ohio State University · Updated on 2025-10-20

76

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

AtorvaStatin Postpartum and Reduction of Cardiovascular risK

Who Can Participate

Age: 20Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postpartum individuals
  • At least 20 years old and able to give informed consent
  • Diagnosed with gestational hypertension or preeclampsia before or during delivery based on ACOG criteria
  • Able to speak English
Not Eligible

You will not qualify if you...

  • Prior use of HMG-CoA reductase inhibitors (statins) before or during pregnancy
  • Known familial hypercholesterolemia or pre-existing hyperlipidemia with LDL >190 before pregnancy or on statins before delivery
  • Planning to breastfeed for 6 months or longer
  • Planning to conceive another pregnancy within 6 months
  • Incarcerated individuals
  • Hypertension caused by fetal conditions
  • Allergic or contraindicated to statins or atorvastatin components
  • Active liver disease or unexplained persistent elevated liver enzymes
  • History of rhabdomyolysis or muscle disease
  • HIV positive due to drug interaction concerns
  • History of solid organ transplant
  • Active cancer
  • Current use of medications that interact with atorvastatin, such as cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, or digoxin

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

Tracy C Bank, MD

CONTACT

M

Maged Costantine, MD, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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