Daily Aspirin Treatment After Preeclampsia

NCT06168461 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 202303799
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

preeclampsia

Outcome Measures

Primary Outcomes (3)

• magnitude of microvascular endothelial function

  skin blood flow response to acetylcholine delivered via intradermal microdialysis

  baseline, 12 weeks

• magnitude of brachial artery endothelial function

  brachial artery flow mediated dilation

  baseline, 12 weeks

• magnitude of microvascular endothelin-1 mediated constriction

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

  baseline, 12 weeks

Secondary Outcomes (1)

• magnitude of microvascular nitric oxide-dependent dilation

  baseline, 12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo pill taken once daily at bedtime for 12 weeks

Drug: Placebo

aspirin

EXPERIMENTAL

162mg aspirin taken once daily at bedtime for 12 weeks

Drug: Aspirin

Interventions

Aspirin DRUG

162mg aspirin capsule

aspirin

Placebo DRUG

placebo capsule

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anna Stanhewicz, PhD: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Anna Reid-Stanhewicz, PHD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: December 13, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)