AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Gestational Hypertension; Hypertensive Disorders of Pregnancy
• Intervention / Treatment: Drug: Atorvastatin 10 mg; Drug: Placebo

Detailed Description

Individuals will be followed for up to 1 year to address the following specific aims:

Specific Aim 1: To determine if among individuals diagnosed with hypertensive disorders of pregnancy (HDP), the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months, lowers cardiovascular risk, as measured by the Framingham Risk Score for Cardiovascular Disease (30 year risk, primary outcome) and cardiovascular risk prediction model (PREVENT, secondary outcome) compared with placebo; and if the benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment.

Specific Aim 2: To determine if among individuals diagnosed with HDP the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers the frequency of metabolic syndrome, improves lipid levels, and reduces inflammatory markers compared with placebo; and if this benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maged Costantine, MD, MBA; Phone Number: 614-293-2222; Email: Maged.Costantine@osumc.edu
• Study Contact Backup: Name: Tracy C Bank, MD; Phone Number: 614-293-2222; Email: Tracy.Bank@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
      • Contact: Maged Costantine, MD, MBA; Phone Number: 614-293-2222; Email: Maged.Costantine@osumc.edu
      • Contact: Kara Rood, MD; Phone Number: 614-293-8045; Email: Kara.Rood@osumc.edu
      • Principal Investigator: Kara Rood, MD
      • Principal Investigator: Maged Costantine, MD, MBA
      • Sub-Investigator: Lauren Hassen, MD
      • Sub-Investigator: Sydney Lammers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Postpartum
2. ≥ 20 years old with the ability to give informed consent
3. 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.
4. English speaking

Exclusion Criteria:

1. Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
2. Known familial hypercholesterolemia or pre-existing hyperlipidemia, specifically Low-density Lipoprotein (LDL) >190 prior to pregnancy or diagnosis of hyperlipidemia with prescription of HMG-CoA reductase inhibitor prior to delivery,
3. Plan to breastfeed for >= 6 months,
4. Plan for pregnancy conception in the next 6 months,
5. Incarcerated individuals,
6. Hypertensive diagnosis thought to be secondary to fetal condition,
7. Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
8. Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
9. History of rhabdomyolysis or myopathy,
10. Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
11. History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
12. Active cancer, or
13. Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 mg Atorvastatin; Atorvastatin 10 mg daily for 3 months	Drug: Atorvastatin 10 mg; Participants will be assigned to 10 mg Atorvastatin
Placebo Comparator: Placebo; Identical appearing placebo for 3 months	Drug: Placebo; Participants will be assigned to identical appearing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 30-year Framingham Risk Score for Cardiovascular Disease	Predicts 0-100% risk of "hard" CVD events (coronary death, myocardial infarction, stroke) based on sex, systolic blood pressure, antihypertensive treatment, total and high-density lipoprotein cholesterol, smoking, and diabetes mellitus. A higher number reflects a greater risk of adverse CVD events, whereas a lower number reflects lower risk.	After 3 months of study treatment, up to 9 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Use and Side Effects	Individuals will be contacted monthly via phone call to assess drug tolerability and use using a survey, which reviews any adverse events or concerns related to use of the study drug.	From randomization until 6 months after stopping to use the study drug, up to 9 months
Framingham Risk Score for Cardiovascular Disease 3-6 months following medication cessation	Enrolled individuals will be contacted via telephone at 3-6 months after they complete medication use and will be invited to a visit for a Framingham Risk Score calculation. The Framingham Risk Score predicts 0-100% risk of CVD events, with a higher number reflecting a greater risk of adverse CVD events, whereas a lower number reflects lower risk.	Anytime after 3-6 months of stopping to use the study drug, up to 9 months from randomization
PREVENT (AHA Predicting Risk of CVD Events) score	A glomerular filtration rate will be calculated for each enrolled individual upon enrollment and at the additional biospecimen visits in order to enable calculation of the PREVENT score.	From randomization until 6 months after stopping to use the study drug, up to 9 months
Rates of primary care provider (PCP) visits within 9-12 months of delivery	Enrolled individuals will undergo a telephone survey at 9-12 months postpartum, assessing whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner), and for what reason, since the time of their delivery	From randomization until 6 months after stopping to use the study drug, up to 12 months from delivery
Waist circumference	Waist circumference in centimeters will be measured at the study visits to help identify those with metabolic syndrome (circumference of 88 cm or more).	From randomization until 6 months after stopping to use the study drug, up to 9 months
Fasting glucose	Fasting glucose levels will be measured at the study visits to help identify those with metabolic syndrome (fasting glucose above or equal to 100 mg/dL).	From randomization until 6 months after stopping to use the study drug, up to 9 months
Number of individuals diagnosed with metabolic syndrome	The presence of metabolic syndrome will be defined as 3 or more of the following, which are also listed as individual outcomes: waist circumference greater or equal to 88 cm, triglycerides greater or equal to 150 mg/dL, HDL cholesterol <50 mg/dL, blood pressure greater or equal to 130/85, and fasting glucose greater or equal to 100 mg/dL.	From randomization until 6 months after stopping to use the study drug, up to 9 months
Lipid levels	Serum testing for total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides	From randomization until 6 months after stopping to use the study drug, up to 9 months
Hypertension diagnosis & need for antihypertensive therapy	Blood pressure will be measured at the study visits to identify new development of hypertension; enrolled individuals will be asked if they have started medication for hypertension	From randomization until 6 months after stopping to use the study drug, up to 9 months
Diabetes diagnosis & need for anti-glycemic therapy	Hemoglobin A1C will be measured at the study visits to identify new development of diabetes mellitus (HbA1C > 6.5%) and individuals will be asked if they have started anti-glycemic medication	From randomization until 6 months after stopping to use the study drug, up to 9 months
Systolic blood pressure		From randomization until 6 months after stopping to use the study drug, up to 9 months
Estimated glomerular filtration rate		From randomization until 6 months after stopping to use the study drug, up to 9 months
High-sensitivity C-reactive protein (Hs-CRP) level		From randomization until 6 months after stopping to use the study drug, up to 9 months
Lipoprotein (a) level		From randomization until 6 months after stopping to use the study drug, up to 9 months
Apolipoprotein (b) level		From randomization until 6 months after stopping to use the study drug, up to 9 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Tracy C Bank, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Preeclampsia; Hypertensive disorders of pregnancy; Atorvastatin treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin
• Other Study ID Numbers: 2024H0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No