Daily Aspirin Treatment After Preeclampsia

Study Overview
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Brief Summary
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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.

Official Title
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Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo pill taken once daily at bedtime for 12 weeks | Drug: Placebo<br>* placebo capsule<br>|
| Experimental: aspirin<br>162mg aspirin taken once daily at bedtime for 12 weeks | Drug: Aspirin<br>* 162mg aspirin capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| magnitude of microvascular nitric oxide-dependent dilation | skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis | baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia