Treatment With Aspirin After Preeclampsia: TAP Trial

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.

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

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Malamo Countouris

  lead OTHER

Principal Investigators

• Alisse K Hauspurg, MD · UPMC Magee Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-29

Primary Completion

2026-06-01

Completion

2027-06-01

FDA Drug

Yes

Countries

• United States

Study Locations