Actively Recruiting
AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk
Led by Ohio State University · Updated on 2025-10-20
76
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of atorvastatin to reduce cardiovascular risk in postpartum individuals who had hypertensive disorders during pregnancy, such as preeclampsia or gestational hypertension. This trial aims to see if taking atorvastatin after stopping breastfeeding can lower the risk of heart disease and improve related health markers. The study is a randomized, placebo-controlled trial designed to assess these effects over time. Participants will be randomly assigned to receive either atorvastatin 10 mg daily or a matching placebo, starting after they stop breastfeeding and continuing for 3 months. The study includes two groups: one taking atorvastatin and the other taking placebo pills that look identical. After the treatment period, participants will be followed for up to one year to monitor lasting effects and health outcomes. During the study, participants will undergo regular assessments including cardiovascular risk scoring, blood tests for cholesterol and inflammatory markers, measurements of waist size and blood pressure, and evaluations for metabolic syndrome. Researchers will also track medication use, side effects, and healthcare visits. The main measurement is the 30-year Framingham Risk Score assessed after 3 months of treatment. Safety and effectiveness will be monitored throughout the study and after stopping the medication for several months.
CONDITIONS
Brief Title
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postpartum individuals
- Age 20 to 50 years with ability to give informed consent
- Diagnosed with gestational hypertension or preeclampsia before or during delivery using ACOG criteria
- English speaking
You will not qualify if you...
- Use of HMG-CoA reductase inhibitors (statins) before or during pregnancy
- Known familial hypercholesterolemia or pre-existing hyperlipidemia with LDL >190 or prior statin use
- Plan to breastfeed for 6 months or longer
- Plan to conceive within the next 6 months
- Incarcerated individuals
- Hypertension due to fetal condition
- Contraindications or hypersensitivity to atorvastatin or its components
- Active liver disease or unexplained elevated liver enzymes
- History of rhabdomyolysis or myopathy
- HIV positive status
- History of solid organ transplant
- Active cancer
- Current use of certain medications with drug interactions (cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, digoxin)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take atorvastatin 10 mg daily or placebo for 3 months following cessation of breastfeeding to reduce cardiovascular risk.
Visits occur periodically throughout the 3 months of treatment
Duration - 3 to 6 months
Participants are monitored for 3 to 6 months after stopping the study drug to assess persistence of cardiovascular benefits and side effects.
Visits occur periodically during follow-up
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
M
Maged Costantine, MD, MBA
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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