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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
Study Summary
This trial studied genetic, lab & clinical factors associated with low-dose aspirin failure in preventing preeclampsia. Results link a genetic variant to increased platelet function & possible aspirin failure.
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.Check my eligibility
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.See study design
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 ~ at study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,227 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to participants aged 45 and older?
"The cut-off points for enrolment are 18 and 45 years old, respectively."
Answered by AI
Is this experiment recruiting volunteers presently?
"According to clinicaltrials.gov, although this trial was first made available on February 1st 2023 and last updated January 23rd 2023, it is presently not looking for participants. Nevertheless, 83 other trials are currently recruiting individuals at the moment."
Answered by AI
Who has the ability to join this research project?
"This medical study is advancing the treatment of preeclampsia, and has room for 120 participants aged 18 to 45. To qualify for the trial, candidates must have had a past history of preeclampsia with low-dose aspirin in their subsequent gestation; having either experienced recurrence or not. Additionally, they need to have taken aspirin at 81 mg before 16 weeks of gestation as well as reported an adherence rate no less than 80%. Furthermore, applicants should be willing to refrain from taking NSAIDs one week prior platelet function tests."
Answered by AI
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