Pravastatin for Preeclampsia Prevention

(Statin Trial)

No longer recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Statins, Cyclosporine, Fibrates, others

Disqualifiers: HIV, Cancer, Renal disease, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests pravastatin to determine if it can safely prevent preeclampsia, a serious pregnancy condition marked by high blood pressure and organ damage. Researchers aim to understand how the body processes the drug and gather initial safety information. Participants will receive either pravastatin or a placebo (a pill with no active medicine). This trial suits pregnant women at high risk of preeclampsia who have experienced severe early onset preeclampsia in a previous pregnancy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that can interact with statins, such as cyclosporine, fibrates, and others. If you are currently using any of these, you may need to discontinue them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pravastatin has been tested for safety in pregnant women at high risk of preeclampsia. In these studies, most women tolerated pravastatin well and did not experience serious side effects. However, due to limited safety data, caution remains necessary. More information is needed to understand how pravastatin affects both mothers and their babies during pregnancy.

The FDA has already approved pravastatin to lower cholesterol in non-pregnant individuals. This approval indicates its safety for general use, but its safety during pregnancy is still under investigation. While early results are encouraging, further research is required to fully understand its safety for pregnant women. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for preeclampsia?

Pravastatin is unique because it offers a novel approach to preventing preeclampsia, a pregnancy complication that currently has limited treatment options. Unlike traditional treatments that focus mainly on managing symptoms like high blood pressure and protein in the urine, pravastatin targets the underlying causes of preeclampsia by improving endothelial function and reducing inflammation. Researchers are excited about pravastatin because it is a well-known cholesterol-lowering drug with a good safety profile, and its potential to prevent or reduce the severity of preeclampsia could significantly improve outcomes for both mothers and babies.

What evidence suggests that pravastatin might be an effective treatment for preeclampsia?

Research has shown that pravastatin, which participants in this trial may receive, might help lower the risk of preeclampsia in pregnant women. One analysis found that women taking pravastatin had a 61% lower chance of developing preeclampsia compared to those who did not take it. Another study found that pravastatin reduced the rate of preeclampsia from 12% in the placebo group to 6% in the group taking the medication. These findings suggest that pravastatin could help prevent preeclampsia in high-risk pregnancies. ^{1 2 4 6 7}

Who Is on the Research Team?

Maged Costantine, MD

Principal Investigator

UTexasGalveston; Ohio State

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older at high risk of severe early onset preeclampsia, with a single pregnancy between 12 and nearly 17 weeks along. They must have normal liver function and be willing to attend study visits. Women can't join if they have certain health conditions like active liver disease, kidney issues, HIV, or are using drugs that interact badly with statins.

Inclusion Criteria

Normal serum transaminase concentrations in the last 6 months

I had a severe pregnancy complication early and delivered before 34 weeks in a past pregnancy.

I was induced into labor at 34 weeks of pregnancy and delivered within 48 hours.

Exclusion Criteria

My pregnancy does not have known major genetic issues or malformations.

I am allergic to pravastatin, have active liver disease, or a history of muscle issues.

Participating in another intervention study that influences the outcomes of this study, plans to deliver in a non-network site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pravastatin or placebo daily during pregnancy to evaluate safety and pharmacokinetics

Up to 30 weeks

Regular visits for monitoring adverse events and pharmacokinetic sampling

Follow-up

Participants are monitored for maternal and fetal adverse events until delivery and up to 120 days postpartum

Up to 120 days postpartum

Post-delivery visits for monitoring neonatal outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Pravastatin

Trial Overview The study is testing whether pravastatin can prevent preeclampsia in high-risk pregnant women. Participants will either receive pravastatin daily or a placebo (a pill without the drug). The team will measure how the body processes the drug and monitor safety.

How Is the Trial Designed?

Group I: Pravastatin Group Active Control 1 Intervention

Pregnant women at high-risk for preeclampsia who are taking pravastatin during their pregnancy.

Group II: Control Group Placebo Group 1 Intervention

Pregnant women who are at high-risk for developing preeclampsia who are taking a placebo during their pregnancy.

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

Approved in United States as Pravachol for:

• High Cholesterol
• Hyperlipoproteinemia
• Myocardial Infarction - Prophylaxis
• Revascularization Procedures - Prophylaxis

Approved in European Union as Pravastatin for:

• Hypercholesterolaemia
• Mixed dyslipidaemia
• Prevention of cardiovascular events

Approved in Canada as Pravastatin for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular events

Approved in Japan as Pravastatin for:

• Hypercholesterolemia
• Familial hypercholesterolemia

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9880057/

Pravastatin in preeclampsia: A meta-analysis and systematic ... Pravastatin treatment reduced the incidence of preeclampsia by 61% in the pravastatin-treated group compared to the untreated group. 3.4. Pravastatin treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03944512

NCT03944512 | Pravastatin to Prevent Preeclampsia This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.053963

Pravastatin Versus Placebo in Pregnancies at High Risk of ... It was hypothesized that pravastatin would reduce the rate of preeclampsia by 50%, from 12% in the placebo group to 6% in the pravastatin group.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4884459/

Safety and Pharmacokinetics of Pravastatin Used for the ... This study provides preliminary safety and pharmacokinetic data regarding the use of pravastatin for preventing preeclampsia in high-risk pregnant women.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01717586

NCT01717586 | Pravastatin for Prevention of Preeclampsia The purpose of this pilot study is to evaluate the maternal-fetal safety and pharmacokinetic (PK) profiles of pravastatin when used in pregnant women at high- ...

6. ajog.org ajog.org/article/S0002-9378(15)02586-7/fulltext

Safety and pharmacokinetics of pravastatin used for the ... This study provides preliminary safety and pharmacokinetic data regarding the use of pravastatin for preventing preeclampsia in high-risk pregnant women.

7. binasss.sa.cr binasss.sa.cr/bibliotecas/bhm/mar23/20.pdf

Aspirin and Pravastatin for Preeclampsia Prevention in ... Safety Data. LDA is safe to use in pregnancy. A systematic review ... maternal safety of pravastatin use in pregnancy are limited to the more recent trials.