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?

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.

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.

Is atorvastatin (Lipitor) safe for humans?

There is no specific safety data on atorvastatin (Lipitor) for postpartum cardiovascular risk after preeclampsia in the provided research articles. ^{1 2 3 4 5}

How does the drug Atorvastatin differ from other treatments for postpartum cardiovascular risk after preeclampsia?

Atorvastatin is unique because it is primarily used to lower cholesterol and reduce the risk of heart disease, which may help address the increased cardiovascular risk after preeclampsia, a condition for which there are few specialized post-pregnancy care programs. ^{1 5 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

English speaking

At least 24 hours after delivery

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. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Health After Preeclampsia: Patient and Provider Perspective. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Association of pre-eclampsia with metabolic syndrome and increased risk of cardiovascular disease in women: A systemic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic Hypertension and the Risk of Readmission for Postpartum Cardiovascular Complications. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Preeclampsia as a female-specific risk factor for chronic hypertension. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Risk of future cardiovascular diseases in different years postpartum after hypertensive disorders of pregnancy: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Metabolic syndrome and pre-eclampsia. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular disease risk factors after early-onset preeclampsia, late-onset preeclampsia, and pregnancy-induced hypertension. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The association between preeclampsia and the risk of metabolic syndrome after delivery: a meta-analysis. [2022]