protocolSection identificationModule nctId: NCT06281665, orgStudyIdInfo id: STUDY23080099, secondaryIdInfos id: K23HL168356, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL168356, briefTitle: Treatment With Aspirin After Preeclampsia: TAP Trial, acronym: TAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Alisse Hauspurg, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital., conditionsModule conditions: Hypertensive Disorder of Pregnancy, conditions: Pre-Eclampsia, conditions: Hypertension, conditions: Eclampsia, conditions: Gestational Hypertension, conditions: Cardiovascular Diseases, conditions: Toxemia, conditions: Pregnancy Complications, conditions: Vascular Diseases, conditions: Hypertension, Pregnancy Induced, conditions: Hypertension;Pre-Eclamptic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Participants, Investigators and outcomes assessors will be blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Low-dose aspirin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent of participants eligible, enrolled and retained (feasibility), secondaryOutcomes measure: Study visit systolic BP, secondaryOutcomes measure: Study visit diastolic BP, secondaryOutcomes measure: Study visit systolic BP, secondaryOutcomes measure: Study visit diastolic BP, secondaryOutcomes measure: Study visit mean arterial pressure, secondaryOutcomes measure: Study visit mean arterial pressure, secondaryOutcomes measure: Anti-hypertensive medication use, secondaryOutcomes measure: Anti-hypertensive medication use, secondaryOutcomes measure: Therapeutic intensity score, secondaryOutcomes measure: Therapeutic intensity score, secondaryOutcomes measure: Mean home systolic blood pressure, secondaryOutcomes measure: Mean home diastolic blood pressure, secondaryOutcomes measure: Mean home mean arterial pressure, secondaryOutcomes measure: Mean daytime systolic blood pressure, secondaryOutcomes measure: Mean nocturnal systolic blood pressure, secondaryOutcomes measure: Mean daytime diastolic blood pressure, secondaryOutcomes measure: Mean nocturnal diastolic blood pressure, secondaryOutcomes measure: Mean nocturnal mean arterial pressure, secondaryOutcomes measure: Mean daytime mean arterial pressure, secondaryOutcomes measure: Mean overall mean arterial pressure, secondaryOutcomes measure: Mean overall systolic blood pressure, secondaryOutcomes measure: Mean overall diastolic blood pressure, secondaryOutcomes measure: Classification of hypertension, secondaryOutcomes measure: Classification of hypertension, secondaryOutcomes measure: Endothelial function EC50%, secondaryOutcomes measure: Endothelial function EC50%, secondaryOutcomes measure: Endothelial function Emax, secondaryOutcomes measure: Endothelial function Emax, secondaryOutcomes measure: Endothelial function change in Emax, secondaryOutcomes measure: Endothelial function change in EC50%, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in mean arterial pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Pittsburgh Magee-Womens Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sila Yavan, MS, role: CONTACT, phone: 412-417-4981, email: yavans@upmc.edu, contacts name: Alisse K Hauspurg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False