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

Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Aspirin 81Mg Non-enteric coated Tab

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aspirin; 81mg aspirin daily	Drug: Aspirin 81Mg Non-enteric coated Tab; one tab daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); March of Dimes
• Investigators: Principal Investigator: Rupsa C Boelig, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 20F.911; 3R21HD101127-01S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Following publication of data, 12 months following study completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes