Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Phase 1

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Aspirin 81Mg Non-enteric coated Tab

• Registration Number: NCT04645004
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Study Start: 2020-12-29
• Primary Completion: 2024-01-11
• Study Completion: 2024-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin 81Mg Non-enteric coated Tab	81mg aspirin daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Urinary thromboxane	4 week post initiation	ELISA based quantification of urindary dehydrothromboxane B2

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States