NCT05709483RecruitingEarly phase 1
Predictors of Aspirin Failure in Preeclampsia Prevention
Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 11 Jan 2023
- Start date
- 13 Apr 2023
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Rockefeller University
- NCT number
- NCT05709483
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 130
- From 13 Apr 2023 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any clinically significant adverse reaction to aspirin on prior exposure
Other illness
- Known bleeding disorder based on personal or family history
- History of kidney or liver impairment
- Chronic hypertension (systolic blood pressure \>140 mmHG or diastolic pressure \>90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician)
- Diabetes mellitus
- Current known malignancy
- History of hemorrhagic stroke
Age
- Age \<18 years or \>45 years
- \<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.
Other
- Current pregnancy
- Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants).
- Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons
- Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
- Healthy controls:
Who the study is looking for
- 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.
- 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%
- Subsequent pregnancy lasted beyond 20 weeks of gestation
- 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.
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rockefeller University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.