Treatment With Aspirin After Preeclampsia: TAP Trial

NCT ID: NCT06281665

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2027-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The control group will receive similar appearing placebo daily for 6 months.

Intervention Group

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

Group Type: EXPERIMENTAL

Low-dose aspirin

Intervention Type: DRUG

The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.

Interventions

Low-dose aspirin

The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.

Intervention Type: DRUG

Placebo

The control group will receive similar appearing placebo daily for 6 months.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Alisse Hauspurg

OTHER

Sponsor Role: lead

Responsible Party

Alisse Hauspurg

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alisse K Hauspurg, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Magee Women's Hospital

Locations

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alisse K Hauspurg, MD

Role: CONTACT

janickia@upmc.edu

412-641-1381

Sila Yavan, MS

Role: CONTACT

yavans@upmc.edu

4124174981

Facility Contacts

Sila Yavan, MS

Role: primary

yavans@upmc.edu

4124174981

Other Identifiers

K23HL168356

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23080099

Identifier Type: -

Identifier Source: org_study_id