Treatment With Aspirin After Preeclampsia: TAP Trial (TAP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Toxemia; Hypertension; Pregnancy Complications; Eclampsia; Pre-Eclampsia; Hypertensive Disorder of Pregnancy; Gestational Hypertension; Hypertension, Pregnancy Induced; Hypertension;Pre-Eclamptic
• Intervention / Treatment: Drug: Placebo; Drug: Low-dose aspirin

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alisse K Hauspurg, MD; Phone Number: 412-641-1381; Email: janickia@upmc.edu
• Study Contact Backup: Name: Sila Yavan, MS; Phone Number: 4124174981; Email: yavans@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Magee-Womens Hospital
      • Contact: Sila Yavan, MS; Phone Number: 412-417-4981; Email: yavans@upmc.edu
      • Principal Investigator: Alisse K Hauspurg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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
• Aspirin use during pregnancy or planned aspirin use in the postpartum period.
• Pre-pregnancy diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Similar appearing placebo pill daily for 6 months will be given to subjects.	Drug: Placebo; The control group will receive similar appearing placebo daily for 6 months.
Experimental: Intervention Group; Low-dose [81 mg] aspirin pill daily for 6 months will be given to subjects	Drug: Low-dose aspirin; The intervention group will receive low-dose [81 mg] aspirin pill daily for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study visit systolic BP	Mean study visit systolic BP	2 months postpartum
Study visit diastolic BP	Mean study visit diastolic BP	2 months postpartum
Study visit systolic BP	Mean study visit systolic BP	6 months postpartum
Study visit diastolic BP	Mean study visit diastolic BP	6 months postpartum
Study visit mean arterial pressure	Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))	2 months postpartum
Study visit mean arterial pressure	Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))	6 months postpartum
Anti-hypertensive medication use	Use of anti-hypertensive medication (percent of participants)	2 months postpartum
Anti-hypertensive medication use	Use of anti-hypertensive medication (percent of participants)	6 months postpartum
Therapeutic intensity score	Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome)	2 months postpartum
Therapeutic intensity score	Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome)	6 months postpartum
Mean home systolic blood pressure	Mean home systolic blood pressure	delivery through 6 months postpartum
Mean home diastolic blood pressure	Mean home diastolic blood pressure	delivery through 6 months postpartum
Mean home mean arterial pressure	Mean home mean arterial pressure	delivery through 6 months postpartum
Mean daytime systolic blood pressure	Mean daytime systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean nocturnal systolic blood pressure	Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean daytime diastolic blood pressure	Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean nocturnal diastolic blood pressure	Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean nocturnal mean arterial pressure	Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean daytime mean arterial pressure	Mean daytime mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean overall mean arterial pressure	Mean overall mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean overall systolic blood pressure	Mean overall systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Mean overall diastolic blood pressure	Mean overall diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Classification of hypertension	Stage 1, stage 2 hypertension (percent of participants with each stage)	2 months postpartum
Classification of hypertension	Stage 1, stage 2 hypertension (percent of participants with each stage)	6 months postpartum
Endothelial function EC50%	EC50% from microiontophoresis	2 months postpartum
Endothelial function EC50%	EC50% from microiontophoresis	6 months postpartum
Endothelial function Emax	Emax from microiontophoresis	2 months postpartum
Endothelial function Emax	Emax from microiontophoresis	6 months postpartum
Endothelial function change in Emax	Change in Emax between visits	2 to 6 months postpartum
Endothelial function change in EC50%	Change in EC50% between visits	2 to 6 months postpartum
Change in systolic blood pressure	Change in study visit mean systolic blood pressure between visits	2 to 6 months postpartum
Change in diastolic blood pressure	Change in study visit mean diastolic blood pressure between visits	2 to 6 months postpartum
Change in mean arterial pressure	Change in study visit mean arterial pressure between visits	2 to 6 months postpartum

Collaborators and Investigators

• Sponsor: Alisse Hauspurg
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Alisse K Hauspurg, MD, UPMC Magee Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Toxemia; Hypertension; Cardiovascular Diseases; Vascular Diseases; Eclampsia; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: STUDY23080099; K23HL168356 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data (including data dictionaries) will be shared at the discretion of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available.
• IPD Sharing Time Frame: Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
• IPD Sharing Access Criteria: NHLBI data repository request process
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes