Treatment With Aspirin After Preeclampsia: TAP Trial

Malamo Countouris

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Low-dose aspirin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06281665

K23HL168356 (U.S. NIH Grant/Contract)

STUDY23080099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Similar appearing placebo pill daily for 6 months will be given to subjects.

Treatment:

Drug: Placebo

Intervention Group

Experimental group

Description:

Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects

Treatment:

Drug: Low-dose aspirin