PreeclampsiaPhase 1/2APROACH-PKNCT04645004
Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy
A Phase 1/2 study testing Aspirin 81Mg Non-enteric coated Tab in people with Preeclampsia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy Read more about this study
- Who is it for?
- Ages 13 to 55 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin 81Mg Non-enteric coated Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 15 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 13 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- <16 weeks' gestational age
- Singleton pregnancy
- Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
- ≥1 risk factor:
- Chronic hypertension
- Type I or II diabetes
Show all 15Show fewer
- Previous preeclampsia
- Renal disease
- Autoimmune disease (SLE) OR
- ≥2 risk factor:
- Nulliparity
- IVF pregnancy
- Black race or socioeconomic disadvantaged
- BMI>30
- Prior adverse pregnancy outcome
Who cannot join
- Contraindication to aspirin
- Current or planned use of any other anticoagulation
- Current need for dialysis
- Use of aspirin therapy prior to enrollment in the current pregnancy
- Thrombocytopenia (<150)
- Other known platelet disorder/thrombophilia at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy
Read the detailed description
This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.
- Conditions
- Preeclampsia
- Being tested
- Aspirin 81Mg Non-enteric coated Tab
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81Mg Non-enteric coated TabDrug
one tab daily
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Other | 81mg aspirin daily Receives: Drug: Aspirin 81Mg Non-enteric coated Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
salicylic acid level
time/concentration profile
Measured: 24 hour
serum thromboxane
ELISA based quantification of serum thromboxane B2
Measured: 4 week post initiation
PFA-100
PFA-100 epi closure time (Siemens)
Measured: 4 week post initiation
Secondary outcomes (1)
Urinary thromboxane
ELISA based quantification of urindary dehydrothromboxane B2
Measured: 4 week post initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start29 Dec 2020
- Primary completion11 Jan 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One arm PK/PD study of aspirin in pregnancy1
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes
- Responsible party
- Sponsor
- Investigators
- Rupsa C Boelig, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645004
- Sponsor's protocol ID
- 20F.911
- Other IDs
- 3R21HD101127-01S1
- Acronym
- APROACH-PK
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final results of this study will plan to be submitted for publication within 12 months of completion of analysis of samples. Following publication, a data set excluding any protected health information will be available on request pending agreement on use of data and appropriate IRB approval for data sharing agreement with the outside individuals or institutions requesting data. The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
- ClinicalTrials.gov ID
- NCT04645004
- Acronym / sponsor ID
- APROACH-PK / 20F.911
- Conditions
- Preeclampsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 25 Nov 2020 (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.
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy
Detailed description
This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm PK/PD study of aspirin in pregnancy1
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Other | Drug: Aspirin 81Mg Non-enteric coated Tab81mg aspirin daily |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- <16 weeks' gestational age
- Singleton pregnancy
- Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
- ≥1 risk factor:
Key exclusion criteria (6 listed)
- Contraindication to aspirin
- Current or planned use of any other anticoagulation
- Current need for dialysis
- Use of aspirin therapy prior to enrollment in the current pregnancy
- Thrombocytopenia (<150)
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 |
|---|---|---|
| Aspirin 81Mg Non-enteric coated Tabone tab daily | Drug | Aspirin |
Primary outcome
salicylic acid level
Time frame: 24 hour
time/concentration profile
serum thromboxane
Time frame: 4 week post initiation
ELISA based quantification of serum thromboxane B2
PFA-100
Time frame: 4 week post initiation
PFA-100 epi closure time (Siemens)
1 secondary outcome
Urinary thromboxane
Time frame: 4 week post initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. Final results of this study will plan to be submitted for publication within 12 months of completion of analysis of samples. Following publication, a data set excluding any protected health information will be available on request pending agreement on use of data and appropriate IRB approval for data sharing agreement with the outside individuals or institutions requesting data. The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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. This study is not recruiting at the moment.
Rupsa C Boelig, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aspirin 81Mg Non-enteric coated Tab in people with Preeclampsia, run by Thomas Jefferson 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 15 inclusion and 6 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: finished, as of the sponsor's last update on 18 Apr 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salicylic acid level (time frame: 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.