Daily Aspirin Treatment After Preeclampsia

Early Phase 1

Recruiting

• Conditions: Preeclampsia
• Interventions: Drug: Placebo; Drug: Aspirin

• Registration Number: NCT06168461
• Lead Sponsor: Anna Stanhewicz, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo pill taken once daily at bedtime for 12 weeks
aspirin	Aspirin	162mg aspirin taken once daily at bedtime for 12 weeks

Primary Outcome Measures

Name	Time	Method
magnitude of microvascular endothelial function	baseline, 12 weeks	skin blood flow response to acetylcholine delivered via intradermal microdialysis
magnitude of microvascular endothelin-1 mediated constriction	baseline, 12 weeks	skin blood flow response to endothelin-1 delivered via intradermal microdialysis
magnitude of brachial artery endothelial function	baseline, 12 weeks	brachial artery flow mediated dilation

Secondary Outcome Measures

Name	Time	Method
magnitude of microvascular nitric oxide-dependent dilation	baseline, 12 weeks	skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States