Pravastatin for Preeclampsia

(Pravastatin Trial)

Recruiting at11 trial locations

Overseen by Maged Costantine, MD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: The George Washington University Biostatistics Center

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.

Research Team

Monica Longo, MD, PHD

Principal Investigator

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

Rebecca Clifton, PhD

Principal Investigator

The George Washington University Biostatistics Center

Victoria Pemberton, RNC, MS, CCRC

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Maged Costantine, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for high-risk pregnant women aged 16 or older who have had preeclampsia with preterm delivery before 34 weeks. They must be between 12 and nearly 17 weeks pregnant, with normal liver function, not on certain medications, and planning to deliver at a network site.

Inclusion Criteria

If you are pregnant, you are only eligible if you are carrying one or two babies and if any reduction of more than two babies occurred before 14 weeks of pregnancy.

I am 16 or older and can make my own medical decisions.

Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria

You have uncontrolled hypothyroidism, HIV, chronic kidney disease, or are taking certain medications that could interact with the study drug. You are also excluded if you are involved in another study that could affect the results, plan to give birth at a non-network site, or have previously participated in this trial during a past pregnancy.

Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion.

I am not allergic to pravastatin, do not have active liver disease, and am not pregnant.

Treatment Details

Interventions

• Placebo (Other)
• Pravastatin (HMG-CoA reductase inhibitor)

Trial Overview The study tests if pravastatin can prevent preeclampsia in high-risk pregnancies. It's a double-blind trial where half the participants get pravastatin and the other half get a placebo daily until delivery, with follow-ups postpartum and for children up to age five.

Participant Groups

Group I: Pravastatin Experimental Treatment 1 Intervention

20 mg pravastatin daily

Group II: Placebo Placebo Group 1 Intervention

Identical appearing daily placebo

Pravastatin is already approved in Canada, Japan for the following indications:

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 George Washington University Biostatistics Center

Lead Sponsor

Trials

27

Recruited

111,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland