AtorvaStatin Postpartum and Reduction of Cardiovascular risK

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06632379
Phase
PHASE4
Status
Recruiting
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Conditions

  • Gestational Hypertension
  • Hypertensive Disorders of Pregnancy
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin 10 mg — DRUG
    Participants will be assigned to 10 mg Atorvastatin
  • Placebo — DRUG
    Participants will be assigned to identical appearing placebo

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
Oct 2025
Primary completion
Sep 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 10 mg Atorvastatin
    Atorvastatin 10 mg daily for 3 months
  • Placebo Comparator: Placebo
    Identical appearing placebo for 3 months

Primary Outcome Measure

The 30-year Framingham Risk Score for Cardiovascular Disease [ Time Frame: After 3 months of study treatment, up to 9 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Maged Costantine, MD, MBA
[email protected]
614-293-2222
Kara Rood, MD
[email protected]
614-293-8045
Kara Rood, MD (PRINCIPAL_INVESTIGATOR)
Maged Costantine, MD, MBA (PRINCIPAL_INVESTIGATOR)
Lauren Hassen, MD (SUB_INVESTIGATOR)
Sydney Lammers, MD (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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