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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether atorvastatin improves a heart and blood vessel risk score after birth in people who had high blood pressure during pregnancy. The 76 participants will get either 10 mg of atorvastatin or a placebo (a pill with no active drug) for 3 months, starting after they stop breastfeeding.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have given birth.
  • Are age 20 or older and able to understand and agree to join the study.
  • Have a care team diagnosis of high blood pressure that started during pregnancy, or preeclampsia (a pregnancy condition with high blood pressure), before or during the hospital stay for delivery.
  • Speak English.

Who can't join

  • Were prescribed a statin (a cholesterol-lowering drug) before or during pregnancy; have inherited high cholesterol; or had LDL (“bad” cholesterol) over 190 before pregnancy or high cholesterol treated with a statin before delivery.
  • Plan to breastfeed for 6 months or longer, or plan to become pregnant in the next 6 months.
  • Are in jail or prison, or have high blood pressure thought to be caused by a condition in the baby.
  • Cannot safely take statins, or are allergic to atorvastatin or any of its ingredients.
  • Have active liver disease, including liver inflammation or ongoing unexplained liver blood tests at least twice the normal upper limit; or have had muscle disease or serious muscle breakdown.
  • Have HIV or have had a solid organ transplant.
  • Have active cancer.
  • Currently take medicines that may interact with atorvastatin: cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, or digoxin.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. Breastfeeding 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.

Study sites (1)

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