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Antiplatelet Agent

Aspirin for High Blood Pressure During Pregnancy (ASPIRIN Trial)

Phase 4
Recruiting
Led By Denise Sholtens, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders)
Planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of birth
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to compare the effectiveness of 162 mg/day aspirin versus 81 mg/day aspirin in preventing high blood pressure disorders during pregnancy. The study will also look at factors affecting how well

Who is the study for?
This trial is for individuals at risk of developing hypertensive disorders during pregnancy, such as pre-eclampsia or high blood pressure. The study aims to find out if a higher dose of aspirin can prevent these conditions better than a lower dose.
What is being tested?
The trial is testing two different doses of aspirin: one group will take 162 mg per day and another will take 81 mg per day. Researchers want to see which dosage is more effective in preventing high blood pressure-related complications in pregnancy.
What are the potential side effects?
Aspirin may cause side effects like gastrointestinal issues (e.g., stomach pain, heartburn), bleeding problems, allergic reactions, and possibly other risks that are not yet known.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have allergies to aspirin or conditions that make it unsafe for me to take it.
Select...
I plan to use aspirin during pregnancy for a heart condition or after a stroke.
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I am under 14 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypertensive Disorder of Pregnancy (HDP)
Secondary study objectives
Adherence to aspirin
Bleeding complications (maternal)
Bleeding complications (neonatal)
+11 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 81 mg AspirinExperimental Treatment1 Intervention
Treatment A consisting of 81mg of aspirin (1 pill of 81mg \& 1 matching placebo) daily
Group II: 162 mg AspirinExperimental Treatment1 Intervention
Treatment B consisting of 162mg of aspirin (2 pills, each of 81mg) daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 81 mg
2019
Completed Phase 4
~1070
Aspirin 162 mg
2019
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
644,382 Total Patients Enrolled
Northwestern UniversityOTHER
1,647 Previous Clinical Trials
947,910 Total Patients Enrolled
Preeclampsia FoundationOTHER
3 Previous Clinical Trials
40,151 Total Patients Enrolled
~7161 spots leftby Jan 2029
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