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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
Rockefeller University
RECRUITING
New York
Contact Information
Primary
Recruitment Office
RUcares@Rockefeller.edu
1-800-782-2737
Backup
Amihai Rottenstreich, MD
arottenstr@rockefeller.edu
+1-2123277245
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 130
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Rockefeller University

This content was sourced from clinicaltrials.gov