Daily Aspirin Treatment After Preeclampsia

Preeclampsia Clinical Trial

Official title:

Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168461
• Other study ID #: 202303799
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2023
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: Anna Reid-Stanhewicz, PHD
• Phone: 319-467-1732
• Email: anna-stanhewicz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Anna Stanhewicz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	magnitude of microvascular endothelial function	skin blood flow response to acetylcholine delivered via intradermal microdialysis	baseline, 12 weeks
Primary	magnitude of brachial artery endothelial function	brachial artery flow mediated dilation	baseline, 12 weeks
Primary	magnitude of microvascular endothelin-1 mediated constriction	skin blood flow response to endothelin-1 delivered via intradermal microdialysis	baseline, 12 weeks
Secondary	magnitude of microvascular nitric oxide-dependent dilation	skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis	baseline, 12 weeks