AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Recruiting · NCT06632379 · Interventional (participants receive a specific treatment) · Lead sponsor: Ohio State University
View the official record on ClinicalTrials.gov →Interventions studied
Atorvastatin 10 mgPlacebo
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.
Who can take part
Age range
20 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Postpartum
- ≥ 20 years old with the ability to give informed consent
- 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.
- English speaking
Exclusion criteria
- Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
- 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,
- Plan to breastfeed for \>= 6 months,
- Plan for pregnancy conception in the next 6 months,
- Incarcerated individuals,
- Hypertensive diagnosis thought to be secondary to fetal condition,
- Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
- Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
- History of rhabdomyolysis or myopathy,
- Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
- History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
- Active cancer, or
- Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.
Where it is running
1 location listed across 1 US state.
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus, Ohio, United States