Rivaroxaban for Breastfeeding

(LACT Trial)

Overseen By Rupsa C Boelig, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Thomas Jefferson University

Must be taking: Rivaroxaban

Disqualifiers: Pregnant, Renal dysfunction, Liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the medicine rivaroxaban (a blood thinner) transfers into breast milk when taken by postpartum women. The researchers will test two different doses: one for prevention and one for treatment, to observe their effects on milk over time. Women who have given birth within the last 6 weeks, are stable in terms of blood loss, and have specific weight or blood clotting histories are suitable candidates. Participants, whether breastfeeding or not, must meet specific criteria related to their health and delivery details. As a Phase 1 trial, this research aims to understand how rivaroxaban works in people, allowing participants to contribute to foundational knowledge about the medication's effects.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that rivaroxaban is likely to be safe for humans?

Research has shown that when breastfeeding mothers take rivaroxaban, only small amounts appear in breast milk, much lower than what would affect a baby. One study found the level in breast milk to be about 9.73 ng/mL before each dose and 53.9 ng/mL six hours after each dose. These levels are less than 2% of what would be needed to thin a baby's blood.

Another study found no safety concerns for breastfeeding women taking rivaroxaban. However, there is not enough information yet to fully understand its effects on breastfed babies or milk production. So far, these findings suggest that rivaroxaban is generally safe for infants when mothers are breastfeeding. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using rivaroxaban in breastfeeding mothers because it offers a potentially safer and more convenient option for preventing blood clots postpartum. Unlike traditional anticoagulants like warfarin, which require frequent blood monitoring and dietary restrictions, rivaroxaban is a direct oral anticoagulant taken once daily without the need for regular blood tests. This makes it a simpler and more manageable choice for new moms. Additionally, rivaroxaban has a lower risk of drug interactions, which is a significant advantage for those who need to juggle multiple medications.

What evidence suggests that rivaroxaban could be effective for breastfeeding?

This trial will evaluate the safety of rivaroxaban for breastfeeding mothers. Studies have shown that when breastfeeding mothers take rivaroxaban at doses of 15 to 30 mg daily, only a tiny amount enters breast milk, too low to affect babies. Research on mothers using rivaroxaban while breastfeeding has not found any side effects in their babies. This suggests that the drug, at these doses, is unlikely to cause problems for breastfed babies. However, more research is needed to confirm these findings. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking postpartum women within 6 weeks of delivery, who are stable and either not breastfeeding or breastfeeding a healthy full-term infant. Participants must need prophylactic anticoagulation due to high BMI or history of VTE, or therapeutic anticoagulation as per ACOG guidelines.

Inclusion Criteria

I speak English.

I am not breastfeeding.

I gave birth within the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 10 mg or 20 mg of rivaroxaban daily starting by the first postpartum day

6 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rivaroxaban

Trial Overview The study aims to measure how the blood thinner Rivaroxaban is passed into breast milk when taken at doses meant for preventing (10 MG) or treating (20 MG) blood clots after giving birth.

How Is the Trial Designed?

Group I: Therapeutic or Intermediate dose rivaroxaban Active Control 1 Intervention

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.

Group II: Prophylactic rivaroxaban Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK500742/

Rivaroxaban - Drugs and Lactation Database (LactMed®) Maternal doses of rivaroxaban of 15 to 30 mg daily produce low levels in milk that are considerably below doses (<2%) required for anticoagulation in infants.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06831474

Excretion of Rivaroxaban in Human Breast Milk Our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. Our novel contributions to the existing body ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/products/xarelto/medical-content/use-of-xarelto-during-pregnancy-and-lactation

Use of XARELTO During Pregnancy and Lactation XARELTO has been detected in human milk. There are insufficient data to determine the effects of XARELTO on the breastfed child or on milk ...

4. liebertpub.com liebertpub.com/doi/10.1089/bfm.2019.0124

Rivaroxaban Treatment in Two Breastfeeding Mothers Conclusions. The results of this study suggest that transfer of rivaroxaban into human milk is quite low. However, caution must be exercised until further ...

5. sps.nhs.uk sps.nhs.uk/articles/using-oral-anticoagulants-during-breastfeeding/

Using oral anticoagulants during breastfeeding – SPS From the limited published evidence, no side effects have been observed in infants after exposure to rivaroxaban through breast milk.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049384824001166

Potential treatment option of rivaroxaban for breastfeeding ... The current case series showed that there were no pharmacokinetic concerns about the use of rivaroxaban in breastfeeding women with breastfeeding infants, which ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31746638/

Rivaroxaban Concentration in Breast Milk During ... The mean minimum and maximum rivaroxaban concentrations in breast milk were 9.73 ng/mL before each dose and 53.9 ng/mL at 6 hours after each dose, respectively.