[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06281665":3,"trial-entities:NCT06281665":184,"trial-summary:NCT06281665":188},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":29,"study_type":30,"primary_purpose":13,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":48,"secondary_outcomes":53,"sex":138,"minimum_age":139,"maximum_age":140,"healthy_volunteers":141,"eligibility_criteria":142,"std_ages":153,"locations":155,"central_contacts":174,"overall_officials":179,"references":182,"see_also_links":183},"NCT06281665","STUDY23080099","Treatment With Aspirin After Preeclampsia: TAP Trial","RECRUITING","2027-09-01","2026-06","2026-06-04","2024-05-29","Malamo Countouris","OTHER",true,"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\u002For microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.","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 identical appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two 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.",[18,19,20,21,22,23,24,25,26,27,28],"Hypertensive Disorder of Pregnancy","Pre-Eclampsia","Hypertension","Eclampsia","Gestational Hypertension","Cardiovascular Diseases","Toxemia","Pregnancy Complications","Vascular Diseases","Hypertension, Pregnancy Induced","Hypertension;Pre-Eclamptic",[20],"INTERVENTIONAL",[32],"PHASE4",{"count":34,"type":35},60,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","Low-dose aspirin","The intervention group will receive low-dose \\[81 mg\\] aspirin pill daily for 6 months.",[42],"Intervention Group",{"type":38,"name":44,"description":45,"armGroupLabels":46},"Placebo","The control group will receive similar appearing placebo daily for 6 months.",[47],"Placebo Group",[49],{"measure":50,"description":51,"timeFrame":52},"Percent of participants eligible, enrolled and retained (feasibility)","To determine the feasibility of conducting a single-site randomized controlled trial of 6 months of postpartum low-dose aspirin vs. placebo in women with preeclampsia.","Baseline to approximately 6 months postpartum",[54,58,61,63,64,67,68,71,72,75,76,79,81,83,86,89,92,95,98,101,104,107,110,113,114,117,118,121,122,126,129,132,135],{"measure":55,"description":56,"timeFrame":57},"Study visit systolic BP","Mean study visit systolic BP","2 months postpartum",{"measure":59,"description":60,"timeFrame":57},"Study visit diastolic BP","Mean study visit diastolic BP",{"measure":55,"description":56,"timeFrame":62},"6 months postpartum",{"measure":59,"description":60,"timeFrame":62},{"measure":65,"description":66,"timeFrame":57},"Study visit mean arterial pressure","Mean study visit mean arterial pressure ((2\\*diastolic BP + systolic BP \u002F 3))",{"measure":65,"description":66,"timeFrame":62},{"measure":69,"description":70,"timeFrame":57},"Anti-hypertensive medication use","Use of anti-hypertensive medication (percent of participants)",{"measure":69,"description":70,"timeFrame":62},{"measure":73,"description":74,"timeFrame":57},"Therapeutic intensity score","Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome)",{"measure":73,"description":74,"timeFrame":62},{"measure":77,"description":77,"timeFrame":78},"Mean home systolic blood pressure","delivery through 6 months postpartum",{"measure":80,"description":80,"timeFrame":78},"Mean home diastolic blood pressure",{"measure":82,"description":82,"timeFrame":78},"Mean home mean arterial pressure",{"measure":84,"description":85,"timeFrame":62},"Mean daytime systolic blood pressure","Mean daytime systolic blood pressure on ambulatory blood pressure monitoring",{"measure":87,"description":88,"timeFrame":62},"Mean nocturnal systolic blood pressure","Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring",{"measure":90,"description":91,"timeFrame":62},"Mean daytime diastolic blood pressure","Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring",{"measure":93,"description":94,"timeFrame":62},"Mean nocturnal diastolic blood pressure","Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring",{"measure":96,"description":97,"timeFrame":62},"Mean nocturnal mean arterial pressure","Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring",{"measure":99,"description":100,"timeFrame":62},"Mean daytime mean arterial pressure","Mean daytime mean arterial pressure on ambulatory blood pressure monitoring",{"measure":102,"description":103,"timeFrame":62},"Mean overall mean arterial pressure","Mean overall mean arterial pressure on ambulatory blood pressure monitoring",{"measure":105,"description":106,"timeFrame":62},"Mean overall systolic blood pressure","Mean overall systolic blood pressure on ambulatory blood pressure monitoring",{"measure":108,"description":109,"timeFrame":62},"Mean overall diastolic blood pressure","Mean overall diastolic blood pressure on ambulatory blood pressure monitoring",{"measure":111,"description":112,"timeFrame":57},"Classification of hypertension","Stage 1, stage 2 hypertension (percent of participants with each stage)",{"measure":111,"description":112,"timeFrame":62},{"measure":115,"description":116,"timeFrame":57},"Endothelial function EC50%","EC50% from microiontophoresis",{"measure":115,"description":116,"timeFrame":62},{"measure":119,"description":120,"timeFrame":57},"Endothelial function Emax","Emax from microiontophoresis",{"measure":119,"description":120,"timeFrame":62},{"measure":123,"description":124,"timeFrame":125},"Endothelial function change in Emax","Change in Emax between visits","2 to 6 months postpartum",{"measure":127,"description":128,"timeFrame":125},"Endothelial function change in EC50%","Change in EC50% between visits",{"measure":130,"description":131,"timeFrame":125},"Change in systolic blood pressure","Change in study visit mean systolic blood pressure between visits",{"measure":133,"description":134,"timeFrame":125},"Change in diastolic blood pressure","Change in study visit mean diastolic blood pressure between visits",{"measure":136,"description":137,"timeFrame":125},"Change in mean arterial pressure","Change in study visit mean arterial pressure between visits","FEMALE","18 Years","55 Years",false,{"inclusion":143,"exclusion":146,"raw_text":152},[144,145],"Postpartum individuals ≥18 years old","Preeclampsia diagnosis",[147,148,149,150,151],"Fetal anomaly","Multiple gestation","Pre-pregnancy hypertension","Allergy or contraindication to low-dose aspirin","Pre-pregnancy diabetes","Inclusion Criteria:\n\n* Postpartum individuals ≥18 years old\n* Preeclampsia diagnosis\n\nExclusion Criteria:\n\n* Fetal anomaly\n* Multiple gestation\n* Pre-pregnancy hypertension\n* Allergy or contraindication to low-dose aspirin\n* Pre-pregnancy diabetes",[154],"ADULT",[156],{"facility":157,"status":7,"city":158,"state":159,"zip":160,"country":161,"contacts":162,"geoPoint":171},"University of Pittsburgh Magee-Womens Hospital","Pittsburgh","Pennsylvania","15213","United States",[163,168],{"name":164,"role":165,"phone":166,"email":167},"Sila Yavan, MS","CONTACT","4124174981","yavans@upmc.edu",{"name":169,"role":170},"Alisse K Hauspurg, MD","PRINCIPAL_INVESTIGATOR",{"lat":172,"lon":173},40.44062,-79.99589,[175,178],{"name":169,"role":165,"phone":176,"email":177},"412-641-1381","janickia@upmc.edu",{"name":164,"role":165,"phone":166,"email":167},[180],{"name":169,"affiliation":181,"role":170},"UPMC Magee Women's Hospital",[],[],{"nct_id":4,"conditions":185,"biomarkers":187},[186],"Preeclampsia",[],{"nct_id":4,"found":14,"summary":189,"prompt_version":199},{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This is a pilot, randomized, double-blind study where 60 participants will be assigned by chance to receive either low-dose aspirin or a placebo. Neither you nor your doctor will know which you are receiving.","completed","TAP Trial: Aspirin After Preeclampsia","This study, called the TAP Trial, is looking at whether low-dose aspirin (81 mg) can help women recover after experiencing preeclampsia (a serious high blood pressure condition during pregnancy). You would receive either low-dose aspirin or a placebo (an inactive pill that looks the same) daily for six months after delivery. The main goal of this pilot study is to see if it's practical to conduct a larger trial like this and to assess if aspirin helps improve blood vessel function and lower blood pressure. To join, you must be a woman between 18 and 55 years old who has recently had preeclampsia. You cannot participate if you have certain conditions like pre-pregnancy high blood pressure or diabetes, or an allergy to aspirin. The study is currently unclear about its recruitment status and plans to enroll 60 participants.","Participants will be followed for approximately 6 months postpartum.",138,"You would take a pill daily for six months and monitor your blood pressure at home. You would also have three study visits involving blood pressure measurements, blood draws, questionnaires, and a test called microiontophoresis.","Not stated in the trial record.",[39,44],"v2"]