AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorOhio State University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Plan to breastfeed for >= 6 months,
Plan for pregnancy conception in the next 6 months,
Trial design
Design model
Parallel
Treatments tested in this trial
Atorvastatin 10 mg
DrugParticipants will be assigned to 10 mg Atorvastatin
Placebo
DrugParticipants will be assigned to identical appearing placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: 10 mg AtorvastatinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After 3 months of study treatment, up to 9 months after enrollmentSecondary outcomes
1
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.
Time frame
From randomization until 6 months after stopping to use the study drug, up to 9 months2
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.
Time frame
Anytime after 3-6 months of stopping to use the study drug, up to 9 months from randomization3
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.
Time frame
From randomization until 6 months after stopping to use the study drug, up to 9 months4
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
Time frame
From randomization until 6 months after stopping to use the study drug, up to 12 months from deliverySponsors and contacts
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Source ClinicalTrials.gov