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

Thomas Jefferson University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Preeclampsia

Treatments: Drug: Aspirin 81Mg Non-enteric coated Tab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04645004

20F.911

3R21HD101127-01S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 13 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Aspirin

Other group

Description:

81mg aspirin daily

Treatment:

Drug: Aspirin 81Mg Non-enteric coated Tab