NCT06632379 AtorvaStatin Postpartum and Reduction of Cardiovascular risK
| NCT ID | NCT06632379 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University |
| Condition | Hypertensive Disorders of Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 76 participants in total. It began in 2025-10-03 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Tracy C Bank, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06632379 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 50 Years, studying Hypertensive Disorders of Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06632379 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06632379 currently recruiting?
Yes, NCT06632379 is actively recruiting participants. Contact the research team at Tracy.Bank@osumc.edu for enrollment information.
Where is the NCT06632379 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06632379 clinical trial?
NCT06632379 is sponsored by Ohio State University. The principal investigator is Tracy C Bank, MD at Ohio State University. The trial plans to enroll 76 participants.