Predictors of Aspirin Failure in Preeclampsia Prevention

Part of paid clinical trials in New York, New York.

Sponsor
Rockefeller University
Study ID
NCT05709483
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Aspirin — DRUG
    Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
Oct 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Women with prior history of preeclampsia who received aspirin in subsequent gestation
    Single-dose of enteric-coated 81 mg aspirin
  • No Intervention: Healthy volunteers
    In this group, no aspirin will be given, as blood draw will not be performed at all among the healthy volunteers. The group of healthy volunteers will serve only for the SNP assay development.

Primary Outcome Measure

Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention [ Time Frame: At study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rockefeller UniversityNew YorkNew York10065
Amihai Rottenstreich, MD
[email protected]
212-327-7245

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By research site
Rockefeller University· New York, NY

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