Daily Aspirin Treatment After Preeclampsia

Anna Stanhewicz, PhD

Status and phase: Enrolling; Early Phase 1

Conditions: Preeclampsia

Treatments: Drug: Placebo; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT06168461

202303799

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo pill taken once daily at bedtime for 12 weeks

Treatment:

Drug: Placebo

aspirin

Experimental group

Description:

162mg aspirin taken once daily at bedtime for 12 weeks

Treatment:

Drug: Aspirin