Excretion of Rivaroxaban in Human Breast Milk

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT06831474
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Milk Collection
  • Breastfeeding
  • Postpartum
  • Rivaroxaban
  • VTE (Venous Thromboembolism)
  • VTE Prophylaxis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rivaroxaban 10 MG Oral Tablet — DRUG
    10mg rivaroxaban daily
  • Rivaroxaban 20 MG Oral Tablet — DRUG
    20mg rivaroxaban daily

Study Details

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

Key Dates

Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Prophylactic rivaroxaban
    Patients will receive 10 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for dose 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.
  • Active Comparator: Therapeutic or Intermediate dose rivaroxaban
    Patients will receive 20 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.

Primary Outcome Measure

Concentration of rivaroxaban in breast milk [ Time Frame: Postpartum day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Sophie Green, MD
[email protected]
215-955-5000
Rupsa C Boelig, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Thomas Jefferson University Hospital· Philadelphia, PA

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