Atorvastatin for Postpartum Cardiovascular Risk After Preeclampsia

(SPARK Trial)

Overseen By Maged Costantine, MD, MBA

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Ohio State University

Must not be taking: Cyclosporine, Clarithromycin, Itraconazole, others

Disqualifiers: Hyperlipidemia, Active liver disease, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 3 months

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether atorvastatin, a cholesterol-lowering medication, can reduce heart disease risk following preeclampsia, a pregnancy-related high blood pressure condition. Participants will be randomly assigned to take either atorvastatin or a placebo (a pill with no active medicine) for three months after they stop breastfeeding. The trial seeks individuals who recently gave birth and experienced preeclampsia or gestational hypertension (high blood pressure during pregnancy). As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that might interact with atorvastatin, such as cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin. If you are on any of these, you would need to stop them to participate.

What is the safety track record for atorvastatin?

Studies have shown that atorvastatin, a common cholesterol-lowering drug, is generally safe for people. The FDA has approved it for treating high cholesterol, indicating a well-known safety record. Specific safety information for using atorvastatin in new mothers with high blood pressure is lacking. However, research on similar drugs suggests no major health risks during pregnancy. Overall, atorvastatin is considered safe for adults, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Atorvastatin is unique because it’s being explored for reducing postpartum cardiovascular risk after preeclampsia, a condition that currently lacks targeted treatments for this specific risk. Typically, atorvastatin is used to lower cholesterol, but researchers are excited about its potential to improve cardiovascular health in new mothers who have experienced preeclampsia. This could provide a new approach to managing heart health in a group that’s often overlooked in terms of long-term cardiovascular care. Unlike the standard of care, which mainly focuses on monitoring and managing symptoms post-preeclampsia, atorvastatin acts directly on cardiovascular risk factors.

What evidence suggests that atorvastatin might be an effective treatment for postpartum cardiovascular risk after preeclampsia?

This trial will compare atorvastatin with a placebo to evaluate its effectiveness in reducing postpartum cardiovascular risk after preeclampsia. Research has shown that atorvastatin, a type of statin, effectively lowers the risk of heart problems. Statins commonly reduce cholesterol, helping to prevent heart disease. Studies have also found that statins can improve blood pressure and lower the chance of heart issues. Although specific data on atorvastatin for heart risks after preeclampsia is lacking, statins have been used for similar conditions. Given its proven heart health benefits, atorvastatin may assist postpartum individuals with high blood pressure disorders. ^{1 2 6 7 8}

Who Is on the Research Team?

Tracy C Bank, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

At least 24 hours after delivery

English speaking

I am 20 years or older and can legally consent.

Exclusion Criteria

Incarcerated individuals

Plan to breastfeed for >= 6 months

I have had a solid organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atorvastatin 10 mg daily or placebo for 3 months postpartum

3 months

Monthly phone calls to assess drug tolerability and use

Follow-up

Participants are monitored for cardiovascular risk and metabolic syndrome after treatment

6 months

Visits for Framingham Risk Score calculation and biospecimen collection

Long-term follow-up

Participants are assessed for primary care visits and long-term cardiovascular outcomes

9-12 months

Telephone survey at 9-12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Atorvastatin

Trial Overview 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).

How Is the Trial Designed?

Group I: 10 mg Atorvastatin Active Control 1 Intervention

Atorvastatin 10 mg daily for 3 months

Group II: Placebo Placebo Group 1 Intervention

Identical appearing placebo for 3 months

Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in United States as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease

Approved in Canada as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease

Approved in Japan as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in China as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in Switzerland as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/325199/atorvastatin-postpartum-and-reduction-of-cardiovascular-risk/

AtorvaStatin Postpartum and Reduction of Cardiovascular ... The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8237152/

The role of statins in the prevention of preeclampsia - PMC Earlier reports demonstrated that, when given to women with preterm preeclampsia, pravastatin use was associated with improvement in blood pressure, reduction ...

3. withpower.com withpower.com/trial/atorvastatin-for-postpartum-cardiovascular-risk-after-preeclampsia-c71ac

Atorvastatin for Postpartum Cardiovascular Risk After ... There is no specific safety data on atorvastatin (Lipitor) for postpartum cardiovascular risk after preeclampsia in the provided research articles.

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001212

Opportunities in the Postpartum Period to Reduce ... Adverse pregnancy outcomes are common among pregnant individuals and are associated with long-term risk of cardiovascular disease.

5. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07967-5

The role of statins during pregnancy on maternal risk of ... The findings indicated no statistically significant reduction in pregnancy outcomes including preeclampsia, hypertensive disorders of pregnancy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12341335/

The role of statins during pregnancy on maternal risk of ... Results showed a pooled risk ratio (RR) of 0.78 (95% CI: 0.33 to 1.83, p = 0.57), indicating that statin use during pregnancy was not ...

7. academic.oup.com academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaf592/8239200

Statin use in pregnancy and risk of congenital malformations concluded that there was no evidence of a significant increase in the risk of major congenital malformations or heart defects after first- ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.058983

Statin Use in Pregnancy: Is It Time For a Paradigm Shift? The results of these trials suggest that pravastatin started in the second to third trimester is safe in pregnant women without an increase in ...