AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK): A Randomized Placebo-controlled Trial of Atorvastatin Postpartum for Reduction of Cardiovascular Risk

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
View:

• Postpartum

• ≥ 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.

• English speaking

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Contact Information
Primary
Tracy C Bank, MD
Tracy.Bank@osumc.edu
614-293-2222
Backup
Maged Costantine, MD, MBA
Maged.Costantine@osumc.edu
614-293-2222
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 76
Treatments
Active_comparator: 10 mg Atorvastatin
Atorvastatin 10 mg daily for 3 months
Placebo_comparator: Placebo
Identical appearing placebo for 3 months
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov