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Completed

NCT Number: NCT04295850

Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)

This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

10 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

This proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of HDP through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.

Aim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.

Aim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.

Aim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.

Aim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant singleton, <16 weeks' gestation
  • At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome

Exclusion criteria

  • Contraindication to aspirin
  • Current or planned use of any other anticoagulation
  • Use of aspirin in pregnancy prior to enrollment
  • Known platelet disorder at time of enrollment

Treatment and study plan

Aspirin 81 mg

Drug

Aspirin 81mg daily PO

Primary outcomes

  1. Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP)

    Time frame: 8 months (delivery)

    Difference in first trimester PFA-100 closure time between patients started on aspirin who do and do not develop HDP

  2. Aim 2: Pharmacogenomics of aspirin

    Time frame: 2 weeks

    Difference in PFA-100 closure time with aspirin therapy based on platelet receptor genotype

  3. Aim 3: MicroRNAs and HDP

    Time frame: 8 months (delivery)

    Regression analysis to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels in first trimester are associated with risk of HDP

  4. Aim 4: Aspirin pharmacokinetics in pregnancy

    Time frame: 2 weeks

    Define population based pharmacokinetic model of aspirin in first trimester of pregnancy taking into consideration individual factors (gestational age, race, BMI, genotype)

Secondary outcomes

  1. Aim 1: Aspirin response

    Time frame: 2 weeks

    Multiple logisitic regression analysis to evaluate factors (BMI, race, gestational age, genotype) associated with rate of nonresponse to aspirin therapy defined as (PFA-100>150s)

  2. Aim 1: Prediction of HDP

    Time frame: 8 months (delivery)

    ROCC curve to determine threshold PFA-100 closure time after 1 week of aspirin therapy that is predictive of HDP

  3. Aim 1: First trimester serum thromboxane and risk of HDP

    Time frame: 8 months (delivery)

    Comparison between first trimester serum thromboxane in those with and without hypertensive disorder of pregnancy

  4. Aim 1: Third trimester serum thromboxane and risk of HDP

    Time frame: 8 months (delivery)

    Comparison between third trimester serum thromboxane in those with and without hypertensive disorder of pregnancy

  5. Aim 2: Pharmacogenomics and Pregnancy outcome

    Time frame: 8 months (delivery)

    Multiple regression analysis taking into consideration platelet receptor genotype, race, BMI, and other clinical characteristics and prediction of HDP

  6. Aim 3: MicroRNA profile and aspirin therapy

    Time frame: 2 weeks

    Paired comparison to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels change before and after aspirin therapy

  7. Aim 4: Salicylic acid level and Serum Thromboxane

    Time frame: 2 weeks

    Association between serum salicylic acid with aspirin therapy and serum thromboxane with aspirin therapy

  8. Predictors of preterm birth

    Time frame: 8 months (delivery)

    Multivariable logistic regression to evaluate markers predictive of preterm birth

  9. Predictors of preeclampsia

    Time frame: 8 months (delivery)

    Multivariable logistic regression to evaluate markers predictive of preeclampsia and preterm preeclampsia

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • March of Dimes

Registry information

Acronym: APROACH

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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