Hypertensive Disorders of PregnancyPhase 4SPARKNCT06632379
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
A Phase 4 study testing Atorvastatin 10 mg in people with Hypertensive Disorders of Pregnancy and Preeclampsia, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension
- What is being tested?
- Atorvastatin 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 15 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
- 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,
- Breastfeeding for >= 6 months,
- Plan for pregnancy conception in the next 6 months,
- Incarcerated individuals,
- Hypertensive diagnosis thought to be secondary to fetal condition,
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- Contraindications to HMG-CoA reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component,
- Active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)),
- History of rhabdomyolysis or myopathy,
- Human Immunodeficiency Virus (HIV) positivity, due to potential interactions between atorvastatin and HIV protease inhibitors,
- History of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants
- Active cancer, or
- Current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, rifampin, and digoxin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
Maged Costantine, MD, MBA, 614-293-2222, Maged.Costantine@osumc.edu
Kara Rood, MD, 614-293-8045, Kara.Rood@osumc.edu
About this study
Official title: 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.
Read the 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.
Specific Aim 3: Determine if circulating extracellular vesicles (EVs) from patients with HDP mediate increased CV risk factors and the potential of EV-based therapeutics to dampen these risk factors. We will isolate plasma-derived EVs from individuals with HDP using retrospective samples and perform in vivo and in vitro functional and metabolic assays. We will also analyze the molecular cargo of EVs isolated from individuals in Aim 1 to identify specific pathways that can be targeted via engineered EVs to attenuate the increased CV risk after HDP.
- Being tested
- Atorvastatin 10 mg, Placebo
- Keywords
- Hypertensive disorders of pregnancy, Atorvastatin treatment, Pregnancy, Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10 mgDrug
Participants will be assigned to 10 mg Atorvastatin
PlaceboDrug
Participants will be assigned to identical appearing placebo
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Atorvastatin | Active comparator | Atorvastatin 10 mg daily for 3 months Receives: Drug: Atorvastatin 10 mg |
| Placebo | Placebo comparator | Identical appearing placebo for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 months of study treatment, up to 9 months after enrollment
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
Systolic blood pressure
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
Estimated glomerular filtration rate
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
High-sensitivity C-reactive protein (Hs-CRP) level
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
Lipoprotein (a) level
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
Apolipoprotein (b) level
Measured: From randomization until 6 months after stopping to use the study drug, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start3 Oct 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a double-blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Caroline Bank, Ohio State University
- Investigators
- Tracy C Bank, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632379
- Sponsor's protocol ID
- 2024H0320
- Acronym
- SPARK
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No