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Antiplatelet Agent
Aspirin for Preeclampsia
Phase < 1
Recruiting
Research Sponsored by Anna Stanhewicz, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Be between 18 and 65 years old
Must not have
Bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD)
Current daily aspirin use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Summary
This trial is examining if low dose aspirin therapy after pregnancy can help prevent cardiovascular disease in women who had preeclampsia during pregnancy.
Who is the study for?
This trial is for women aged 18 or older who had preeclampsia within the last 5 years. It's not suitable for those currently on daily aspirin, with skin diseases, using tobacco/nicotine, having liver/kidney disease, taking cholesterol or blood pressure meds, with a history of hypertension before pregnancy, gestational diabetes, currently pregnant, underweight (BMI <18.5), allergic to latex or study drugs, or with bleeding disorders and certain stomach issues.
What is being tested?
The study investigates if low dose aspirin therapy after pregnancy can prevent cardiovascular disease in women who've had preeclampsia by treating lasting blood vessel damage. Participants will either receive daily aspirin treatment or a placebo to compare effectiveness.
What are the potential side effects?
Aspirin may cause side effects like gastrointestinal upset including stomach pain and heartburn; increased risk of bleeding; allergic reactions; and possibly bruising more easily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have bleeding disorders, stomach ulcers, gastritis, GI bleeding, or severe acid reflux.
Select...
I take aspirin every day.
Select...
I am currently taking medication for high blood pressure.
Select...
I have a liver, metabolic condition, or kidney disease with reduced kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
magnitude of brachial artery endothelial function
magnitude of microvascular endothelial function
magnitude of microvascular endothelin-1 mediated constriction
Secondary study objectives
magnitude of microvascular nitric oxide-dependent dilation
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: aspirinExperimental Treatment1 Intervention
162mg aspirin taken once daily at bedtime for 12 weeks
Group II: placeboPlacebo Group1 Intervention
placebo pill taken once daily at bedtime for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Find a Location
Who is running the clinical trial?
Anna Stanhewicz, PhDLead Sponsor
10 Previous Clinical Trials
382 Total Patients Enrolled