Treatment With Aspirin After Preeclampsia: TAP Trial

Study acronym: TAP
StatusRecruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Sep 1, 2026 → Jan 1, 2027
See other at-risk trials from Malamo Countouris

Record History

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  1. Primary completion pushed from Sep 1, 2026 to Jan 1, 2027
    • Study completion pushed from Sep 1, 2027 to Oct 1, 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 4 of 33 entries
  2. Primary completion pushed from Jun 1, 2026 to Sep 1, 2026
    • Study completion pushed from Jun 1, 2027 to Sep 1, 2027
    • Site contact updated
    v8
  3. Lead sponsor: Alisse Hauspurg to Malamo Countouris
    • Site contact updated
    v7
  4. Primary completion date: Jun 1, 2025 to Jun 1, 2026
    • Study completion date: Jun 1, 2026 to Jun 1, 2027
    • Site contact updated
    v6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2025 to Jun 1, 2025
    • Study completion date: Apr 1, 2026 to Jun 1, 2026
    • Start date changed from estimate of Jun 2024 to May 29, 2024
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria shortened, about 12 wordsv4
  2. Start date: May 1, 2024 to Jun 2024v3
  3. Start date: Apr 1, 2024 to May 1, 2024v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06281665
Lead Sponsor Malamo Countouris
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension, Eclampsia, Gestational Hypertension, Cardiovascular Diseases, Toxemia, Pregnancy Complications +3 more
Related terms Cardiovascular Diseases, Eclampsia, Hypertension, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Pregnancy Complications, Toxemia, Vascular Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov