Predictors of Aspirin Failure in Preeclampsia Prevention

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockefeller University
• Treatments: Aspirin

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.

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.