Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy
APROACH-PK
Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
2 other identifiers
interventional
20
1 country
1
Brief Summary
Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
December 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedApril 18, 2024
April 1, 2024
3 years
November 19, 2020
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
salicylic acid level
time/concentration profile
24 hour
serum thromboxane
ELISA based quantification of serum thromboxane B2
4 week post initiation
PFA-100
PFA-100 epi closure time (Siemens)
4 week post initiation
Secondary Outcomes (1)
Urinary thromboxane
4 week post initiation
Study Arms (1)
Aspirin
OTHER81mg aspirin daily
Interventions
Eligibility Criteria
You may qualify if:
- \<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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rupsa C Boelig, MD
Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 25, 2020
Study Start
December 29, 2020
Primary Completion
January 11, 2024
Study Completion
March 15, 2024
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Following publication of data, 12 months following study completion
- Access Criteria
- 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.
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.