NCT06281665

Treatment With Aspirin After Preeclampsia: TAP Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Malamo Countouris · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Hypertension
• Eclampsia
• Gestational Hypertension
• Cardiovascular Diseases
• Toxemia
• Pregnancy Complications
• Vascular Diseases
• Hypertension, Pregnancy Induced
• Hypertension;Pre-Eclamptic

Interventions

Type	Name	Description
DRUG	Low-dose aspirin	The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.
DRUG	Placebo	The control group will receive similar appearing placebo daily for 6 months.

Timeline

• Start date: 2024-05-29
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-02-28
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study