RECRUITING

Predictors of Aspirin Failure in Preeclampsia Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-13

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05709483

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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:	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:

Inclusion Criteria

Exclusion 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:

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:

Contacts and Locations

Study Contact

Recruitment Office

CONTACT

1-800-782-2737

RUcares@Rockefeller.edu

Amihai Rottenstreich, MD

CONTACT

+1-2123277245

arottenstr@rockefeller.edu

Principal Investigator

Amihai Rottenstreich, MD

PRINCIPAL_INVESTIGATOR

Rockefeller University

Study Locations (Sites)

Rockefeller University

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Rockefeller University

Amihai Rottenstreich, MD, PRINCIPAL_INVESTIGATOR, Rockefeller University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2023-04-13

Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

Preeclampsia