RecruitingPhase 4NCT06632379

AtorvaStatin Postpartum and Reduction of Cardiovascular risK

AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk


Sponsor

Ohio State University

Enrollment

76 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a common cholesterol-lowering medication called atorvastatin (a statin) can help reduce heart disease risk in people who had high blood pressure or preeclampsia during pregnancy. Preeclampsia is a pregnancy complication involving dangerously high blood pressure, and people who experience it are at higher long-term risk for heart problems. **You may be eligible if...** - You recently gave birth (postpartum) - You are 20 years old or older - You were diagnosed with high blood pressure or preeclampsia during or just before your delivery - You speak English **You may NOT be eligible if...** - You took a statin (cholesterol medication) before or during pregnancy - You have a known cholesterol disorder - You plan to breastfeed for 6 months or more - You plan to become pregnant within the next 6 months - You have active liver disease, a history of severe muscle breakdown, or HIV - You have had a solid organ transplant - You are currently taking certain medications that interact with atorvastatin (such as cyclosporine or clarithromycin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtorvastatin 10 mg

Participants will be assigned to 10 mg Atorvastatin

DRUGPlacebo

Participants will be assigned to identical appearing placebo


Locations(1)

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

Columbus, Ohio, United States

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NCT06632379


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