Atorvastatin after pregnancy to lower future heart disease risk

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

This study will test whether taking atorvastatin for three months after stopping breastfeeding lowers future cardiovascular risk in people who had high blood pressure during pregnancy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 20 Years to 50 Years
• Sex: Female
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06632379 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled trial enrolling 76 postpartum individuals with hypertensive disorders of pregnancy who have stopped breastfeeding. Participants are randomized to atorvastatin 10 mg daily or matching placebo for three months and are followed for up to one year. The primary outcome is change in the Framingham 30-year cardiovascular risk score, with secondary outcomes including the PREVENT risk model, metabolic syndrome frequency, lipid levels, and inflammatory markers. The study will also assess whether any benefits persist 3–6 months after stopping the study medication.

Who should consider this trial

Good fit: Ideal candidates are postpartum individuals aged 20 or older diagnosed with gestational hypertension or preeclampsia who have stopped breastfeeding, are not taking statins, and are not planning pregnancy within six months.

Not a fit: People already on HMG-CoA reductase inhibitors, those with familial hypercholesterolemia or very high pre-pregnancy LDL, those planning to breastfeed six months or more, or those planning pregnancy soon are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, short-course postpartum atorvastatin could lower long-term cardiovascular risk and improve cholesterol and inflammatory markers in people who had hypertensive disorders of pregnancy.

How similar studies have performed: Previous small studies have explored statin use around pregnancy with mixed or limited results, so this specific postpartum atorvastatin strategy is relatively untested.

Eligibility criteria

Inclusion Criteria:

1. Postpartum
2. ≥ 20 years old with the ability to give informed consent
3. 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.
4. English speaking

Exclusion Criteria:

1. Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
2. 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,
3. Plan to breastfeed for \>= 6 months,
4. Plan for pregnancy conception in the next 6 months,
5. Incarcerated individuals,
6. Hypertensive diagnosis thought to be secondary to fetal condition,
7. Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
8. Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
9. History of rhabdomyolysis or myopathy,
10. Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
11. History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
12. Active cancer, or
13. Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.

Where this trial is running

Columbus, Ohio

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Tracy C Bank, MD — Ohio State University
• Study coordinator: Tracy C Bank, MD

Conditions Hypertensive Disorders of Pregnancy; Preeclampsia; Gestational Hypertension; Hypertensive disorders of pregnancy; Atorvastatin treatment; Pregnancy