Clinical trial NCT06281665: Treatment With Aspirin After Preeclampsia: TAP Trial
Official title: Treatment With Aspirin After Preeclampsia: TAP Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertensive Disorder of Pregnancy
Pre-Eclampsia
Hypertension
Eclampsia
Gestational Hypertension
Cardiovascular Diseases
Toxemia
Pregnancy Complications
Vascular Diseases
Hypertension, Pregnancy Induced
Hypertension;Pre-Eclamptic
Keywords: Hypertension
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-02-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Postpartum individuals ≥18 years old
* Preeclampsia diagnosis

Exclusion Criteria:

* Fetal anomaly
* Multiple gestation
* Pre-pregnancy hypertension
* Allergy or contraindication to low-dose aspirin
* Pre-pregnancy diabetes

Primary outcomes:
measure: Percent of participants eligible, enrolled and retained (feasibility)
timeFrame: Baseline to approximately 6 months postpartum
Secondary outcomes:
measure: Study visit systolic BP
timeFrame: 2 months postpartum
measure: Study visit diastolic BP
timeFrame: 2 months postpartum
measure: Study visit systolic BP
timeFrame: 6 months postpartum
measure: Study visit diastolic BP
timeFrame: 6 months postpartum
measure: Study visit mean arterial pressure
timeFrame: 2 months postpartum
measure: Study visit mean arterial pressure
timeFrame: 6 months postpartum
measure: Anti-hypertensive medication use
timeFrame: 2 months postpartum
measure: Anti-hypertensive medication use
timeFrame: 6 months postpartum
measure: Therapeutic intensity score
timeFrame: 2 months postpartum
measure: Therapeutic intensity score
timeFrame: 6 months postpartum
measure: Mean home systolic blood pressure
timeFrame: delivery through 6 months postpartum
measure: Mean home diastolic blood pressure
timeFrame: delivery through 6 months postpartum
measure: Mean home mean arterial pressure
timeFrame: delivery through 6 months postpartum
measure: Mean daytime systolic blood pressure
timeFrame: 6 months postpartum
measure: Mean nocturnal systolic blood pressure
timeFrame: 6 months postpartum
measure: Mean daytime diastolic blood pressure
timeFrame: 6 months postpartum
measure: Mean nocturnal diastolic blood pressure
timeFrame: 6 months postpartum
measure: Mean nocturnal mean arterial pressure
timeFrame: 6 months postpartum
measure: Mean daytime mean arterial pressure
timeFrame: 6 months postpartum
measure: Mean overall mean arterial pressure
timeFrame: 6 months postpartum
measure: Mean overall systolic blood pressure
timeFrame: 6 months postpartum
measure: Mean overall diastolic blood pressure
timeFrame: 6 months postpartum
measure: Classification of hypertension
timeFrame: 2 months postpartum
measure: Classification of hypertension
timeFrame: 6 months postpartum
measure: Endothelial function EC50%
timeFrame: 2 months postpartum
measure: Endothelial function EC50%
timeFrame: 6 months postpartum
measure: Endothelial function Emax
timeFrame: 2 months postpartum
measure: Endothelial function Emax
timeFrame: 6 months postpartum
measure: Endothelial function change in Emax
timeFrame: 2 to 6 months postpartum
measure: Endothelial function change in EC50%
timeFrame: 2 to 6 months postpartum
measure: Change in systolic blood pressure
timeFrame: 2 to 6 months postpartum
measure: Change in diastolic blood pressure
timeFrame: 2 to 6 months postpartum
measure: Change in mean arterial pressure
timeFrame: 2 to 6 months postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: UPMC Magee Women's Hospital
name: Alisse K Hauspurg, MD
role: PRINCIPAL_INVESTIGATOR
References: