Study Summary
This trial studied genetic, lab & clinical factors associated with low-dose aspirin failure in preventing preeclampsia. Results link a genetic variant to increased platelet function & possible aspirin failure.
- Prophylaxis of Preeclampsia
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Healthy volunteers
1 of 2
Women with prior history of preeclampsia who received aspirin in subsequent gest...
1 of 2
Active Control
Experimental Treatment
130 Total Participants · 2 Treatment Groups
Primary Treatment: Women with prior history of preeclampsia who received aspirin in subsequent gestation · No Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 45 · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Bokslag A, van Weissenbruch M, Mol BW, de Groot CJ. Preeclampsia; short and long-term consequences for mother and neonate. Early Hum Dev. 2016 Nov;102:47-50. doi: 10.1016/j.earlhumdev.2016.09.007. Epub 2016 Sep 20.
- Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.
- Duley L, Henderson-Smart DJ, Meher S, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004659. doi: 10.1002/14651858.CD004659.pub2.
- Redman CW, Bonnar J, Beilin L. Early platelet consumption in pre-eclampsia. Br Med J. 1978 Feb 25;1(6111):467-9. doi: 10.1136/bmj.1.6111.467.
- Roberts MS, Joyce RM, McLeod LJ, Vial JH, Seville PR. Slow-release aspirin and prostaglandin inhibition. Lancet. 1986 May 17;1(8490):1153-4. doi: 10.1016/s0140-6736(86)91865-9. No abstract available.
- Rolnik, Daniel L., David Wright, Liona C. Poon, Neil O’Gorman, Argyro Syngelaki, Catalina de Paco Matallana, Ranjit Akolekar, et al.. 2017. “Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1704559.
- Tolcher MC, Sangi-Haghpeykar H, Mendez-Figueroa H, Aagaard KM. Low-dose aspirin for preeclampsia prevention: efficacy by ethnicity and race. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100184. doi: 10.1016/j.ajogmf.2020.100184. Epub 2020 Jul 21.
- Johnson JD, Louis JM. Does race or ethnicity play a role in the origin, pathophysiology, and outcomes of preeclampsia? An expert review of the literature. Am J Obstet Gynecol. 2022 Feb;226(2S):S876-S885. doi: 10.1016/j.ajog.2020.07.038. Epub 2020 Jul 24.
- Edelstein LC, Simon LM, Lindsay CR, Kong X, Teruel-Montoya R, Tourdot BE, Chen ES, Ma L, Coughlin S, Nieman M, Holinstat M, Shaw CA, Bray PF. Common variants in the human platelet PAR4 thrombin receptor alter platelet function and differ by race. Blood. 2014 Nov 27;124(23):3450-8. doi: 10.1182/blood-2014-04-572479. Epub 2014 Oct 7.
- Edelstein LC, Simon LM, Montoya RT, Holinstat M, Chen ES, Bergeron A, Kong X, Nagalla S, Mohandas N, Cohen DE, Dong JF, Shaw C, Bray PF. Racial differences in human platelet PAR4 reactivity reflect expression of PCTP and miR-376c. Nat Med. 2013 Dec;19(12):1609-16. doi: 10.1038/nm.3385. Epub 2013 Nov 10.
- 2023. "Predictors of Aspirin Failure in Preeclampsia Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05709483.
Frequently Asked Questions
Is this study open to participants aged 45 and older?
"The cut-off points for enrolment are 18 and 45 years old, respectively." - Anonymous Online Contributor
Is this experiment recruiting volunteers presently?
"According to clinicaltrials.gov, although this trial was first made available on February 1st 2023 and last updated January 23rd 2023, it is presently not looking for participants. Nevertheless, 83 other trials are currently recruiting individuals at the moment." - Anonymous Online Contributor
Who has the ability to join this research project?
"This medical study is advancing the treatment of preeclampsia, and has room for 120 participants aged 18 to 45. To qualify for the trial, candidates must have had a past history of preeclampsia with low-dose aspirin in their subsequent gestation; having either experienced recurrence or not. Additionally, they need to have taken aspirin at 81 mg before 16 weeks of gestation as well as reported an adherence rate no less than 80%. Furthermore, applicants should be willing to refrain from taking NSAIDs one week prior platelet function tests." - Anonymous Online Contributor