Treatment With Aspirin After Preeclampsia: TAP Trial

NCT06281665 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY23080099K23HL168356
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• Percent of participants eligible, enrolled and retained (feasibility)

  To determine the feasibility of conducting a single-site randomized controlled trial of 6 months of postpartum low-dose aspirin vs. placebo in women with preeclampsia.

  Baseline to approximately 6 months postpartum

Secondary Outcomes (33)

• Study visit systolic BP

  2 months postpartum

• Study visit diastolic BP

  2 months postpartum

• Study visit systolic BP

  6 months postpartum

• Study visit diastolic BP

  6 months postpartum

• Study visit mean arterial pressure

  2 months postpartum

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Intervention Group

EXPERIMENTAL

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

Drug: Low-dose aspirin

Interventions

Low-dose aspirin DRUG

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

Intervention Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum individuals ≥18 years old
• Preeclampsia diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Malamo Countouris: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia; Hypertension; Eclampsia; Hypertension, Pregnancy-Induced; Cardiovascular Diseases; Pregnancy Complications; Vascular Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alisse K Hauspurg, MD

  UPMC Magee Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisse K Hauspurg, MD

CONTACT

412-641-1381; janickia@upmc.edu

Sila Yavan, MS

CONTACT

4124174981; yavans@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Investigators and outcomes assessors will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 28, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
• Access Criteria: NHLBI data repository request process

Locations

US (1)