AtorvaStatin Postpartum and Reduction of Cardiovascular risK

Launched by OHIO STATE UNIVERSITY · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called atorvastatin can help improve heart health in women who have experienced high blood pressure during pregnancy, specifically conditions like gestational hypertension and preeclampsia. After giving birth, 76 women will be randomly assigned to receive either atorvastatin or a placebo (a pill with no medication) for three months, starting once they stop breastfeeding. The goal is to see if atorvastatin can lower the risk of future heart problems in these women.

To be eligible for this study, participants must be at least 20 years old, able to speak English, and have been diagnosed with a hypertensive disorder during their pregnancy. They must also be at least 24 hours postpartum. However, certain individuals will not be able to participate, such as those who plan to breastfeed for more than six months, have specific medical conditions, or are taking certain medications that might interact with atorvastatin. If you decide to join this trial, you’ll be contributing to important research that could help improve health outcomes for women after pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 24 hours after delivery
• • 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.