nctId: NCT06281665 id: STUDY23080099 id: K23HL168356 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL168356 briefTitle: Treatment With Aspirin After Preeclampsia: TAP Trial acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-04-04 name: Alisse Hauspurg class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) 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. 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 studyType: INTERVENTIONAL phases: PHASE4 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 masking: TRIPLE maskingDescription: Participants, Investigators and outcomes assessors will be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Low-dose aspirin name: Placebo measure: Percent of participants eligible, enrolled and retained (feasibility) measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit systolic BP measure: Study visit diastolic BP measure: Study visit mean arterial pressure measure: Study visit mean arterial pressure measure: Anti-hypertensive medication use measure: Anti-hypertensive medication use measure: Therapeutic intensity score measure: Therapeutic intensity score measure: Mean home systolic blood pressure measure: Mean home diastolic blood pressure measure: Mean home mean arterial pressure measure: Mean daytime systolic blood pressure measure: Mean nocturnal systolic blood pressure measure: Mean daytime diastolic blood pressure measure: Mean nocturnal diastolic blood pressure measure: Mean nocturnal mean arterial pressure measure: Mean daytime mean arterial pressure measure: Mean overall mean arterial pressure measure: Mean overall systolic blood pressure measure: Mean overall diastolic blood pressure measure: Classification of hypertension measure: Classification of hypertension measure: Endothelial function EC50% measure: Endothelial function EC50% measure: Endothelial function Emax measure: Endothelial function Emax measure: Endothelial function change in Emax measure: Endothelial function change in EC50% measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in mean arterial pressure sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Pittsburgh Magee-Womens Hospital city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sila Yavan, MS role: CONTACT phone: 412-417-4981 email: yavans@upmc.edu name: Alisse K Hauspurg, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False