NCT05709483 Predictors of Aspirin Failure in Preeclampsia Prevention
| NCT ID | NCT05709483 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rockefeller University |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2023-04-13 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Amihai Rottenstreich, MD
PRINCIPAL INVESTIGATOR
Rockefeller University
Frequently Asked Questions
Who can join the NCT05709483 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05709483 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05709483 currently recruiting?
Yes, NCT05709483 is actively recruiting participants. Contact the research team at RUcares@Rockefeller.edu for enrollment information.
Where is the NCT05709483 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05709483 clinical trial?
NCT05709483 is sponsored by Rockefeller University. The principal investigator is Amihai Rottenstreich, MD at Rockefeller University. The trial plans to enroll 130 participants.