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Antiplatelet agent
Aspirin for Preeclampsia Prevention
Phase < 1
Recruiting
Led By Amihai Rottenstreich, MD
Research Sponsored by Rockefeller University
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing low-dose aspirin to prevent preeclampsia in pregnant women, especially Black women who may have higher rates of aspirin failure. Aspirin works by preventing blood clots and improving blood flow in the placenta. Low-dose aspirin has been studied for a long time for its potential to prevent preeclampsia, with mixed results.
Who is the study for?
This trial is for women aged 18-45 who had preeclampsia in a past pregnancy, took low-dose aspirin before the 16th week of their next pregnancy with at least 80% compliance, and did not have significant health issues like bleeding disorders or chronic hypertension. It's not for those currently pregnant or on blood thinners.
What is being tested?
The study looks into why low-dose aspirin sometimes fails to prevent preeclampsia in pregnant women. Researchers are examining genetic factors that might affect how well aspirin works to reduce this risk.
What are the potential side effects?
Aspirin can cause side effects such as stomach pain, heartburn, nausea, and an increased risk of bleeding. In rare cases, it may lead to severe allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 1 hours post single dose 81 mg enteric-coated aspirin
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention
Secondary study objectives
Platelet response to aspirin as assessed by VerifyNow Aspirin Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Platelet response to aspirin as assessed by VerifyNow Base Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Platelet response to aspirin as assessed by aggregometry in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Women with prior history of preeclampsia who received aspirin in subsequent gestationExperimental Treatment1 Intervention
Single-dose of enteric-coated 81 mg aspirin
Group II: Healthy volunteersActive Control1 Intervention
In this group, no aspirin will be given, as blood draw will not be performed at all among the healthy volunteers. The group of healthy volunteers will serve only for the SNP assay development.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Low-dose aspirin is commonly used for the prophylaxis of preeclampsia due to its ability to inhibit platelet aggregation. It works by irreversibly inhibiting the enzyme cyclooxygenase, which decreases the formation of thromboxane A2, a substance that promotes platelet aggregation.
This reduction in platelet aggregation helps to improve blood flow and reduce the risk of developing preeclampsia, a condition characterized by high blood pressure and potential damage to other organ systems. This mechanism is crucial for patients as it helps to mitigate one of the leading causes of pregnancy complications and maternal deaths worldwide.
Effects of plasma on the platelet antiaggregatory action of prostacyclin in pregnancy.
Effects of plasma on the platelet antiaggregatory action of prostacyclin in pregnancy.
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Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
160 Previous Clinical Trials
16,412 Total Patients Enrolled
Amihai Rottenstreich, MDPrincipal InvestigatorRockefeller University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bleeding stroke in the past.I have had kidney or liver problems.I have a known cancer diagnosis.I have a bleeding disorder, either personally or in my family.I am either younger than 18 or older than 45.I am currently taking blood thinners.I have diabetes.I have high blood pressure or I'm taking medication for it.I am under 18, not working or studying at Rockefeller in the Coller lab, and considered healthy by the investigator.I am a woman aged 18-45 with a history of preeclampsia and took low dose aspirin in my next pregnancy, regardless of preeclampsia recurrence.I am a woman aged 18 or older and healthy with no specific conditions.I am willing to stop taking over-the-counter pain relievers like ibuprofen for a week before a blood test.
Research Study Groups:
This trial has the following groups:- Group 1: Women with prior history of preeclampsia who received aspirin in subsequent gestation
- Group 2: Healthy volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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