PreeclampsiaEarly Phase 1NCT05709483
Predictors of Aspirin Failure in Preeclampsia Prevention
A Early Phase 1 study testing Aspirin in people with Preeclampsia, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 1 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years or >45 years
- Any clinically significant adverse reaction to aspirin on prior exposure
- Known bleeding disorder based on personal or family history
- History of kidney or liver impairment
- Current pregnancy
- Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants).
Show all 14Show fewer
- Chronic hypertension (systolic blood pressure >140 mmHG or diastolic pressure >90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician)
- Diabetes mellitus
- Current known malignancy
- History of hemorrhagic stroke
- Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons
- Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
- Healthy controls:
- <18 years of age. B. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons C. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rockefeller University
New York, New York, 10065
Amihai Rottenstreich, MD, 212-327-7245, arottenstr@rockefeller.edu
About this study
Official title: Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol
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.
Read the detailed description
Preeclampsia is among the leading causes of maternal morbidity and mortality worldwide. The pathophysiology underling the occurrence of preeclampsia is multifactorial with many suggested theories. Among the latter, enhanced platelet activation coupled with an imbalance in prostanoid levels have been postulated as being responsible for the pathophysiologic changes in preeclampsia.
Numerous prophylactic interventions have been investigated in order to reduce the rate of gestational hypertensive disorders. It is currently well-established that administration of low-dose aspirin is the most beneficial prophylactic approach.
The major effect of aspirin is to inhibit cyclooxygenase-1 (COX-1), which reduces thromboxane A2 production in platelets and the abnormally increased thromboxane A2/prostaglandin I2 imbalance.
This improves placental function by favoring systemic vasodilatation and inhibiting platelet aggregation. Despite its well-established clinical role in the prevention of preeclampsia, aspirin failure is not uncommon. Nevertheless, the ancestry/genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown.
Higher rates of aspirin failure have been reported in Black women, possibly due to genetic variants. Studies among non-pregnant patients, have identified that racial differences in PAR4 (protease- activated receptor 4) expressed on platelets, are associated with increased platelet function in Blacks compared to whites. A single-nucleotide variant (rs773902) in PAR4 gene (F2RL3), which results in alanine/threonine polymorphism, was shown to largely account for the racial difference in platelet activation by PAR4. The frequency of the variant differs widely between self-declared Black individuals and non-Black individuals, with values of ~65% versus~20%. Thus, it is possible that the variant may contribute to the higher rate of failure of low dose aspirin in the Black population.
The study aim is to evaluate these issues.
- Conditions
- Preeclampsia
- Being tested
- Aspirin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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 group | Role | What they receive |
|---|---|---|
| Women with prior history of preeclampsia who received aspirin in subsequent gestation | Experimental | Single-dose of enteric-coated 81 mg aspirin Receives: Drug: Aspirin |
| Healthy volunteers | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention
We will compare the the allelic frequency of the PAR4 variant (rs773902) between aspirin-responders (no recurrence of preeclampsia) and aspirin non responders (recurrence of preeclampsia despite aspirin)
Measured: At study enrollment
Secondary outcomes (4)
Platelet response to aspirin as assessed by VerifyNow Aspirin Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
In the VerifyNow aspirin assay- arachidonic acid is used as the activator to measure the response of the platelet to aspirin. Aspirin irreversibly inhibits COX-1, the enzyme that catalyzes the first reaction leading to the conversion of arachidonic acid to thromboxane A2, which in turn, activates the GPIIb/IIIa receptor to bind fibrinogen, which leads to platelet aggregation. In the presence of aspirin the aggregation does not occur. This assay will demonstrate whether those who developed preeclampsia despite aspirin administration, have increased platelet aggregation at baseline, at 1 hour following aspirin administration, or both.
Measured: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Platelet response to aspirin as assessed by VerifyNow Base Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
In the VerifyNow Base assay, platelet activation is produced by PAR1 thrombin receptor activating peptide + a PAR4 agonist peptide. Thus, this assay will be used to assess whether there is an enhanced response of the PAR4 peptide in those with the PAR4 variant, or perhaps even in those who did not have a good response to aspirin even if they do not have the variant.
Measured: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Platelet response to aspirin as assessed by aggregometry in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
As in the VerifyNow Base assay, the Base channel includes both PAR1 and PAR4 agonists, we will also perform platelet aggregometry with just the PAR4 agonist peptide, to avoid any confounding effect of the PAR1 peptide. This will be measured at baseline and at 1 hour after aspirin administration. Results will be compared between those who developed preeclampsia depicted aspirin and those who did not experience preeclampsia under aspirin prophylaxis.
Measured: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Thromboxane A2 levels in relation to aspirin success in preeclampsia prevention-measured in ng/mL
Aspirin inhibits the enzyme COX-1 which converts arachidonic acid to thromboxane A2. Therefore, evaluating the end product directly-thromboxane A2 levels-may potentially detect differences between the groups (aspirin responders vs. aspirin non-responders).
Measured: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start13 Apr 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amihai Rottenstreich, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709483
- Sponsor's protocol ID
- ARO-1039
- Status last verified
- Oct 2025
- First submitted
- 11 Jan 2023
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27659865Sibai 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.
PubMed 15733721Duley 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.
PubMed 17443552Redman 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.
PubMed 626836Roberts 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.
PubMed 2871403Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
PubMed 28657417Tolcher 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.
PubMed 33345910Johnson 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.
PubMed 32717255Edelstein 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.
PubMed 25293779Edelstein 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.
PubMed 24216752
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol
- ClinicalTrials.gov ID
- NCT05709483
- Acronym / sponsor ID
- ARO-1039
- Conditions
- Preeclampsia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia is among the leading causes of maternal morbidity and mortality worldwide. The pathophysiology underling the occurrence of preeclampsia is multifactorial with many suggested theories. Among the latter, enhanced platelet activation coupled with an imbalance in prostanoid levels have been postulated as being responsible for the pathophysiologic changes in preeclampsia.
Numerous prophylactic interventions have been investigated in order to reduce the rate of gestational hypertensive disorders. It is currently well-established that administration of low-dose aspirin is the most beneficial prophylactic approach.
The major effect of aspirin is to inhibit cyclooxygenase-1 (COX-1), which reduces thromboxane A2 production in platelets and the abnormally increased thromboxane A2/prostaglandin I2 imbalance.
This improves placental function by favoring systemic vasodilatation and inhibiting platelet aggregation. Despite its well-established clinical role in the prevention of preeclampsia, aspirin failure is not uncommon. Nevertheless, the ancestry/genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown.
Higher rates of aspirin failure have been reported in Black women, possibly due to genetic variants. Studies among non-pregnant patients, have identified that racial differences in PAR4 (protease- activated receptor 4) expressed on platelets, are associated with increased platelet function in Blacks compared to whites. A single-nucleotide variant (rs773902) in PAR4 gene (F2RL3), which results in alanine/threonine polymorphism, was shown to largely account for the racial difference in platelet activation by PAR4. The frequency of the variant differs widely between self-declared Black individuals and non-Black individuals, with values of ~65% versus~20%. Thus, it is possible that the variant may contribute to the higher rate of failure of low dose aspirin in the Black population.
The study aim is to evaluate these issues.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with prior history of preeclampsia who received aspirin in subsequent gestation | Experimental | Drug: AspirinSingle-dose of enteric-coated 81 mg aspirin |
| Healthy volunteers | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (14 listed)
- Age <18 years or >45 years
- Any clinically significant adverse reaction to aspirin on prior exposure
- Known bleeding disorder based on personal or family history
- History of kidney or liver impairment
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinPlatelet 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 | Drug | Women with prior history of preeclampsia who received aspirin in subsequent gestation |
Primary outcome
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention
Time frame: At study enrollment
We will compare the the allelic frequency of the PAR4 variant (rs773902) between aspirin-responders (no recurrence of preeclampsia) and aspirin non responders (recurrence of preeclampsia despite aspirin)
4 secondary outcomes
Platelet response to aspirin as assessed by VerifyNow Aspirin Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Time frame: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Platelet response to aspirin as assessed by VerifyNow Base Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Time frame: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Platelet response to aspirin as assessed by aggregometry in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units
Time frame: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Thromboxane A2 levels in relation to aspirin success in preeclampsia prevention-measured in ng/mL
Time frame: 0 and 1 hours post single dose 81 mg enteric-coated aspirin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Background: PubMed 27659865Bokslag 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.
- Background: PubMed 15733721Sibai 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.
- Background: PubMed 17443552Duley 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.
- Background: PubMed 626836Redman 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.
- Background: PubMed 2871403Roberts 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.
- Background: PubMed 28657417Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
- Background: PubMed 33345910Tolcher 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.
- Background: PubMed 32717255Johnson 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.
- Background: PubMed 25293779Edelstein 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.
- Background: PubMed 24216752Edelstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amihai Rottenstreich, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin in people with Preeclampsia, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Office (1-800-782-2737, RUcares@Rockefeller.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention (time frame: At study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709483, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.