Treatment With Aspirin After Preeclampsia: TAP Trial

Hypertension Clinical Trial

— TAP  

Official title:

Treatment With Aspirin After Preeclampsia: TAP Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281665
• Other study ID #: STUDY23080099
• Secondary ID: K23HL168356
• Status: Recruiting
• Phase: Phase 4
• Start date: May 29, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Alisse K Hauspurg, MD
• Phone: 412-641-1381
• Email: janickia[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Low-dose aspirin
The intervention group will receive low-dose [81 mg] aspirin pill daily for 6 months.
• Placebo
The control group will receive similar appearing placebo daily for 6 months.

Locations

Country	Name	City	State
United States	University of Pittsburgh Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alisse Hauspurg	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study visit systolic BP	Mean study visit systolic BP	2 months postpartum
Secondary	Study visit diastolic BP	Mean study visit diastolic BP	2 months postpartum
Secondary	Study visit systolic BP	Mean study visit systolic BP	6 months postpartum
Secondary	Study visit diastolic BP	Mean study visit diastolic BP	6 months postpartum
Secondary	Study visit mean arterial pressure	Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))	2 months postpartum
Secondary	Study visit mean arterial pressure	Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))	6 months postpartum
Secondary	Anti-hypertensive medication use	Use of anti-hypertensive medication (percent of participants)	2 months postpartum
Secondary	Anti-hypertensive medication use	Use of anti-hypertensive medication (percent of participants)	6 months postpartum
Secondary	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
Secondary	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
Secondary	Mean home systolic blood pressure	Mean home systolic blood pressure	delivery through 6 months postpartum
Secondary	Mean home diastolic blood pressure	Mean home diastolic blood pressure	delivery through 6 months postpartum
Secondary	Mean home mean arterial pressure	Mean home mean arterial pressure	delivery through 6 months postpartum
Secondary	Mean daytime systolic blood pressure	Mean daytime systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean nocturnal systolic blood pressure	Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean daytime diastolic blood pressure	Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean nocturnal diastolic blood pressure	Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean nocturnal mean arterial pressure	Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean daytime mean arterial pressure	Mean daytime mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean overall mean arterial pressure	Mean overall mean arterial pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean overall systolic blood pressure	Mean overall systolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Mean overall diastolic blood pressure	Mean overall diastolic blood pressure on ambulatory blood pressure monitoring	6 months postpartum
Secondary	Classification of hypertension	Stage 1, stage 2 hypertension (percent of participants with each stage)	2 months postpartum
Secondary	Classification of hypertension	Stage 1, stage 2 hypertension (percent of participants with each stage)	6 months postpartum
Secondary	Endothelial function EC50%	EC50% from microiontophoresis	2 months postpartum
Secondary	Endothelial function EC50%	EC50% from microiontophoresis	6 months postpartum
Secondary	Endothelial function Emax	Emax from microiontophoresis	2 months postpartum
Secondary	Endothelial function Emax	Emax from microiontophoresis	6 months postpartum
Secondary	Endothelial function change in Emax	Change in Emax between visits	2 to 6 months postpartum
Secondary	Endothelial function change in EC50%	Change in EC50% between visits	2 to 6 months postpartum
Secondary	Change in systolic blood pressure	Change in study visit mean systolic blood pressure between visits	2 to 6 months postpartum
Secondary	Change in diastolic blood pressure	Change in study visit mean diastolic blood pressure between visits	2 to 6 months postpartum
Secondary	Change in mean arterial pressure	Change in study visit mean arterial pressure between visits	2 to 6 months postpartum