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NCT Number: NCT06168461

Daily Aspirin Treatment After Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Anna Stanhewicz

CONTACT

[email protected]

319-467-1732

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aspirin

Drug

162mg aspirin capsule

Placebo

Drug

placebo capsule

Primary outcomes

  1. magnitude of microvascular endothelial function

    Time frame: baseline, 12 weeks

    skin blood flow response to acetylcholine delivered via intradermal microdialysis

  2. magnitude of brachial artery endothelial function

    Time frame: baseline, 12 weeks

    brachial artery flow mediated dilation

  3. magnitude of microvascular endothelin-1 mediated constriction

    Time frame: baseline, 12 weeks

    skin blood flow response to endothelin-1 delivered via intradermal microdialysis

Secondary outcomes

  1. magnitude of microvascular nitric oxide-dependent dilation

    Time frame: baseline, 12 weeks

    skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Reid-Stanhewicz, PHD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Official study title

Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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