AtorvaStatin Postpartum and Reduction of Cardiovascular risK (SPARK)

The Ohio State University

Status and phase: Enrolling; Phase 4

Conditions: Preeclampsia; Gestational Hypertension; Hypertensive Disorders of Pregnancy

Treatments: Drug: Placebo; Drug: Atorvastatin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06632379

2024H0320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

10 mg Atorvastatin

Active Comparator group

Description:

Atorvastatin 10 mg daily for 3 months

Treatment:

Drug: Atorvastatin 10 mg

Placebo

Placebo Comparator group

Description:

Identical appearing placebo for 3 months

Treatment:

Drug: Placebo