Identifying factors that affect aspirin's effectiveness in preventing preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the genetic, laboratory, and clinical factors that contribute to the failure of low-dose aspirin in preventing preeclampsia, a serious pregnancy complication. Women aged 18-45 with a history of preeclampsia who received aspirin in their subsequent pregnancies will be analyzed to determine the predictors of aspirin failure. The research focuses on the role of genetic variants, particularly in the PAR4 receptor, which may influence platelet function and aspirin efficacy. Participants will undergo platelet function analyses to assess their response to aspirin treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women aged 18-45 years with prior history of preeclampsia who received low dose aspirin in their subsequent gestation and either did or did not have a recurrence of preeclampsia.
2. Aspirin was given in their subsequent pregnancy in a 81 mg dose prior to 16 weeks of gestation, and was taken with a self-reported compliance rate of at least 80%
3. Subsequent pregnancy lasted beyond 20 weeks of gestation
4. Willingness to abstain from non-prescription non-steroidal anti-inflammatory drugs (NSAIDs), which are known to interfere with platelet function assays, for one week prior to platelet function analyses.
5. Healthy controls recruited for SNP assay optimization:

Women aged 18 years or older, with no other specific inclusion criteria that need to be met in order to be enrolled for the study.

Exclusion Criteria:

1. Age \<18 years or \>45 years
2. Any clinically significant adverse reaction to aspirin on prior exposure
3. Known bleeding disorder based on personal or family history
4. History of kidney or liver impairment
5. Current pregnancy
6. Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants).
7. Chronic hypertension (systolic blood pressure \>140 mmHG or diastolic pressure \>90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician)
8. Diabetes mellitus
9. Current known malignancy
10. History of hemorrhagic stroke
11. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons
12. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
13. Healthy controls:

A. \<18 years of age. B. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons C. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.

Where it's running

• Rockefeller University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Amihai Rottenstreich, MD — Rockefeller University
• Study coordinator: Recruitment Office
• Email: RUcares@Rockefeller.edu
• Phone: 1-800-782-2737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.