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NCT06632379RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
76 (estimated)
First submitted
24 Sept 2024
Start date
3 Oct 2025
Primary completion date
15 Sept 2027
Lead sponsor
Ohio State University
NCT number
NCT06632379

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 76
  • From 3 Oct 2025 to the primary completion date, 15 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Other illness

  • Hypertensive diagnosis thought to be secondary to fetal condition,
  • Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
  • 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.

Lab values

  • Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),

Other

  • Breastfeeding for \>= 6 months,
  • Plan for pregnancy conception in the next 6 months,
  • Incarcerated individuals,

Who the study is looking for

  • 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

Age in the registry: 20 years to 50 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.