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Recruiting NCT06168461

Daily Aspirin Treatment After Preeclampsia

Early Phase I Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Placebo.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia

Overview

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.

Interventions

  • Drug Aspirin
    162mg aspirin capsule
  • Drug Placebo
    placebo capsule

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • magnitude of microvascular nitric oxide-dependent dilation [Time frame: baseline, 12 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Iowa — Iowa City

Identifiers

NCT: NCT06168461 · 202303799

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗