Identifying factors that affect aspirin's effectiveness in preventing preeclampsia

Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol

This study is trying to find out why low-dose aspirin sometimes doesn't work to prevent preeclampsia in women who have had it before during their pregnancies.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Rockefeller University (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05709483 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-45 with a prior history of preeclampsia who have taken low-dose aspirin in their subsequent pregnancies.

Not a fit: Patients who are under 18 or over 45 years old, or those with a known bleeding disorder or adverse reactions to aspirin, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prevention strategies for preeclampsia, ultimately reducing maternal and fetal morbidity and mortality.

How similar studies have performed: While the approach of investigating genetic factors in aspirin response is innovative, similar studies have shown varying success in understanding aspirin efficacy in different populations.

Eligibility criteria

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 this trial is running

New York, New York

• Rockefeller University — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Amihai Rottenstreich, MD — Rockefeller University
• Study coordinator: Recruitment Office

Conditions Preeclampsia