Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04645004

Acronym

APROACH-PK

Enrollment

Registered

2020-11-25

Start date

2020-12-29

Completion date

2024-03-15

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Brief summary

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.

Interventions

DRUGAspirin 81Mg Non-enteric coated Tab

one tab daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

One arm PK/PD study of aspirin in pregnancy1

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 55 Years

Healthy volunteers

Inclusion criteria

* \<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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
salicylic acid level	24 hour	time/concentration profile
serum thromboxane	4 week post initiation	ELISA based quantification of serum thromboxane B2
PFA-100	4 week post initiation	PFA-100 epi closure time (Siemens)

Secondary

Measure	Time frame	Description
Urinary thromboxane	4 week post initiation	ELISA based quantification of urindary dehydrothromboxane B2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026