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APROACH-PK: Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Sponsor
Thomas Jefferson University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04645004
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), March of Dimes (Other)
20
Enrollment
1
Location
1
Arm
23.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 81Mg Non-enteric coated Tab
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
One arm PK/PD study of aspirin in pregnancy1One arm PK/PD study of aspirin in pregnancy1
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy
Actual Study Start Date :
Dec 29, 2020
Actual Primary Completion Date :
Jun 22, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Aspirin

81mg aspirin daily

Drug: Aspirin 81Mg Non-enteric coated Tab
one tab daily

Outcome Measures

Primary Outcome Measures

  1. salicylic acid level [24 hour]

    time/concentration profile

  2. serum thromboxane [4 week post initiation]

    ELISA based quantification of serum thromboxane B2

  3. PFA-100 [4 week post initiation]

    PFA-100 epi closure time (Siemens)

Secondary Outcome Measures

  1. Urinary thromboxane [4 week post initiation]

    ELISA based quantification of urindary dehydrothromboxane B2

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04645004
Other Study ID Numbers:
  • 20F.911
  • 3R21HD101127-01S1
First Posted:
Nov 25, 2020
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Pre-Eclampsia
Aspirin

Study Results

No Results Posted as of Aug 16, 2022