Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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