Recruiting
Early Phase 1

Low Dose Aspirin

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT06168461

Conditions

Preeclampsia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Aspirin

Placebo

Study Details

Brief summary:

Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.

Conditions

Preeclampsia

Study ID

NCT06168461

Start date

Nov 1, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • had preeclampsia in the past 5 years,
  • 18 years or older

Exclusion criteria:

  • current daily aspirin use,
  • skin diseases,
  • current tobacco or nicotine use (including vaping),
  • diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
  • statin or other cholesterol-lowering medication,
  • current antihypertensive medication,
  • history of hypertension prior to pregnancy,
  • history of gestational diabetes,
  • currently pregnancy,
  • body mass index <18.5 kg/m2,
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergies to study drugs,
  • bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: placebo

placebo pill taken once daily at bedtime for 12 weeks

experimental: aspirin

162mg aspirin taken once daily at bedtime for 12 weeks

Interventions

Aspirin

162mg aspirin capsule

Placebo

placebo capsule

Primary outcome measure

  • magnitude of microvascular endothelial function [ Time Frame: baseline, 12 weeks ]
  • magnitude of brachial artery endothelial function [ Time Frame: baseline, 12 weeks ]
  • magnitude of microvascular endothelin-1 mediated constriction [ Time Frame: baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Anna Reid-Stanhewicz, PHD

319-467-1732anna-stanhewicz@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Anna Stanhewicz

319-467-1732anna-stanhewicz@uiowa.edu

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • preeclampsia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2025-12-15.