Women with prior history of preeclampsia who received aspirin in subsequent gestation for Prophylaxis of Preeclampsia

Rockefeller University, New York, NY
Prophylaxis of PreeclampsiaAspirin - Drug
Eligibility
18 - 45
Female
What conditions do you have?
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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.

Eligible Conditions
  • Prophylaxis of Preeclampsia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 0 and 1 hours post single dose 81 mg enteric-coated aspirin

Hour 1
Platelet response to aspirin as assessed by VerifyNow Aspirin Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Platelet response to aspirin as assessed by VerifyNow Base Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Platelet response to aspirin as assessed by aggregometry in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Thromboxane A2 levels in relation to aspirin success in preeclampsia prevention-measured in ng/mL
At study enrollment
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention

Trial Safety

Side Effects for

Aspirin
4%Bleeding
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02053909) in the Aspirin ARM group. Side effects include: Bleeding with 4%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Women with prior history of preeclampsia who received aspirin in subsequent gestation
Drug
Experimental Group · 1 Intervention: Aspirin · Intervention Types: Drug
Healthy volunteersNoIntervention Group · 1 Intervention: Healthy volunteers · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 and 1 hours post single dose 81 mg enteric-coated aspirin

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
155 Previous Clinical Trials
16,179 Total Patients Enrolled
Amihai Rottenstreich, MDPrincipal InvestigatorRockefeller University

Eligibility Criteria

Age 18 - 45 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women between the ages of 18 and 45 who have had preeclampsia in a previous pregnancy and took low dose aspirin during their next pregnancy, regardless of whether they had preeclampsia again.
You took a low dose (81 mg) of aspirin during a previous pregnancy before 16 weeks of pregnancy and took it regularly at least 80% of the time.
You have been pregnant for more than 20 weeks.
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.