Hypertensive Disorder of PregnancyPhase 4TAPNCT06281665
Treatment With Aspirin After Preeclampsia: TAP Trial
A Phase 4 study testing Low-dose aspirin in people with Hypertensive Disorder of Pregnancy and Pre-Eclampsia, run by Malamo Countouris at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension
- What is being tested?
- Low-dose aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 1 Oct 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum individuals ≥18 years old
- Preeclampsia diagnosis
Who cannot join
- Fetal anomaly
- Multiple gestation
- Pre-pregnancy hypertension
- Allergy or contraindication to low-dose aspirin
- Pre-pregnancy diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Sila Yavan, MS, 4124174981, yavans@upmc.edu
Alisse K Hauspurg, MD
About this study
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.
Read the 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
- Being tested
- Low-dose aspirin, Placebo
- Keywords
- Hypertension
- Medical subject headings
- Toxemia, Pre-Eclampsia, Hypertension, Eclampsia, Hypertension, Pregnancy-Induced, Cardiovascular Diseases, Pregnancy Complications, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose aspirinDrug
The intervention group will receive low-dose [81 mg] aspirin pill daily for 6 months.
PlaceboDrug
The control group will receive similar appearing placebo daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Similar appearing placebo pill daily for 6 months will be given to subjects. Receives: Drug: Placebo |
| Intervention Group | Experimental | Low-dose [81 mg] aspirin pill daily for 6 months will be given to subjects Receives: Drug: Low-dose aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to approximately 6 months postpartum
Secondary outcomes (33)
Study visit systolic BP
Mean study visit systolic BP
Measured: 2 months postpartum
Study visit diastolic BP
Mean study visit diastolic BP
Measured: 2 months postpartum
Study visit systolic BP
Mean study visit systolic BP
Measured: 6 months postpartum
Study visit diastolic BP
Mean study visit diastolic BP
Measured: 6 months postpartum
Study visit mean arterial pressure
Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))
Measured: 2 months postpartum
Study visit mean arterial pressure
Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))
Measured: 6 months postpartum
Anti-hypertensive medication use
Use of anti-hypertensive medication (percent of participants)
Measured: 2 months postpartum
Anti-hypertensive medication use
Use of anti-hypertensive medication (percent of participants)
Measured: 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)
Measured: 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)
Measured: 6 months postpartum
Mean home systolic blood pressure
Mean home systolic blood pressure
Measured: delivery through 6 months postpartum
Mean home diastolic blood pressure
Mean home diastolic blood pressure
Measured: delivery through 6 months postpartum
Mean home mean arterial pressure
Mean home mean arterial pressure
Measured: delivery through 6 months postpartum
Mean daytime systolic blood pressure
Mean daytime systolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean nocturnal systolic blood pressure
Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean daytime diastolic blood pressure
Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean nocturnal diastolic blood pressure
Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean nocturnal mean arterial pressure
Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean daytime mean arterial pressure
Mean daytime mean arterial pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean overall mean arterial pressure
Mean overall mean arterial pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean overall systolic blood pressure
Mean overall systolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Mean overall diastolic blood pressure
Mean overall diastolic blood pressure on ambulatory blood pressure monitoring
Measured: 6 months postpartum
Classification of hypertension
Stage 1, stage 2 hypertension (percent of participants with each stage)
Measured: 2 months postpartum
Classification of hypertension
Stage 1, stage 2 hypertension (percent of participants with each stage)
Measured: 6 months postpartum
Endothelial function EC50%
EC50% from microiontophoresis
Measured: 2 months postpartum
Endothelial function EC50%
EC50% from microiontophoresis
Measured: 6 months postpartum
Endothelial function Emax
Emax from microiontophoresis
Measured: 2 months postpartum
Endothelial function Emax
Emax from microiontophoresis
Measured: 6 months postpartum
Endothelial function change in Emax
Change in Emax between visits
Measured: 2 to 6 months postpartum
Endothelial function change in EC50%
Change in EC50% between visits
Measured: 2 to 6 months postpartum
Change in systolic blood pressure
Change in study visit mean systolic blood pressure between visits
Measured: 2 to 6 months postpartum
Change in diastolic blood pressure
Change in study visit mean diastolic blood pressure between visits
Measured: 2 to 6 months postpartum
Change in mean arterial pressure
Change in study visit mean arterial pressure between visits
Measured: 2 to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 May 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malamo Countouris
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Malamo Countouris, University of Pittsburgh
- Investigators
- Alisse K Hauspurg, MD, Principal investigator, UPMC Magee Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281665
- Sponsor's protocol ID
- STUDY23080099
- Other IDs
- K23HL168356
- Acronym
- TAP
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.