← Back to Search

Statins

Atorvastatin for Postpartum Cardiovascular Risk After Preeclampsia (SPARK Trial)

Phase 4

Waitlist Available

Led By Tracy C Bank, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 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

Must not have

Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy

History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until 6 months after stopping to use the study drug, up to 12 months from delivery

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to compare the effects of atorvastatin and a placebo on the cardiovascular health of individuals who had high blood pressure during pregnancy. 76 participants will be randomly assigned to take either

Who is the study for?

This trial is for postpartum individuals who had high blood pressure disorders during pregnancy, like pre-eclampsia. They should have stopped breastfeeding before joining the study and will be required to take a pill daily for 3 months.

What is being tested?

The trial is testing if Atorvastatin, a cholesterol-lowering medication, can improve heart health in those who had high blood pressure during pregnancy compared to a placebo (a pill with no active drug).

What are the potential side effects?

Atorvastatin may cause muscle pain, digestive problems, increased liver enzymes or memory loss. However, not everyone experiences these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 20 years or older and can legally consent.

Select...

I have been diagnosed with high blood pressure or preeclampsia during my pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I took cholesterol medication before or during pregnancy.

Select...

I have had a solid organ transplant.

Select...

My cancer is currently active.

Select...

I am HIV positive and aware of potential drug interactions.

Select...

I am not taking medications like cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, or digoxin.

Select...

I do not have active liver disease or unexplained high liver enzyme levels.

Select...

I have had rhabdomyolysis or muscle disease in the past.

Select...

I am allergic or cannot take certain cholesterol medications.

Select...

I have high cholesterol or a family history of it, with LDL levels over 190 before pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until 6 months after stopping to use the study drug, up to 12 months from delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until 6 months after stopping to use the study drug, up to 12 months from delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until 6 months after stopping to use the study drug, up to 12 months from delivery for reporting.