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Antiplatelet Agent
Low-Dose Aspirin for Preeclampsia (TAP Trial)
Phase 4
Recruiting
Led By Alisse K Hauspurg, MD
Research Sponsored by Alisse Hauspurg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Pre-pregnancy hypertension
Aspirin use during pregnancy or planned aspirin use in the postpartum period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 6 months postpartum
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to test if taking low-dose aspirin after preeclampsia in the immediate postpartum period can help improve blood vessel recovery. They will enroll up to 60 participants
Who is the study for?
This trial is for postpartum individuals over 18 who were diagnosed with preeclampsia. It's not open to those with pre-pregnancy hypertension or diabetes, allergies to aspirin, multiple gestations, fetal anomalies, or anyone who used aspirin during pregnancy.
What is being tested?
The TAP Trial is testing if low-dose aspirin can help improve blood vessel function and lower blood pressure after preeclampsia. Participants will be randomly given either aspirin or a placebo and monitored through visits involving BP checks and other tests.
What are the potential side effects?
Low-dose aspirin may cause side effects like gastrointestinal issues (like stomach pain), bleeding problems, allergic reactions in some people, but many take it without serious issues.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had high blood pressure before getting pregnant.
Select...
I am taking or plan to take aspirin during or after my pregnancy.
Select...
I am allergic to or cannot take low-dose aspirin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 to 6 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 6 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of participants eligible, enrolled and retained (feasibility)
Secondary study objectives
Anti-hypertensive medication use
Change in diastolic blood pressure
Change in mean arterial pressure
+22 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects
Group II: Placebo GroupPlacebo Group1 Intervention
Similar appearing placebo pill daily for 6 months will be given to subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-dose aspirin
2019
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
Alisse HauspurgLead Sponsor
2 Previous Clinical Trials
170 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,883 Total Patients Enrolled
Alisse K Hauspurg, MDPrincipal InvestigatorUPMC Magee Women's Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled