A Phase 1 interventional study of Rivaroxaban 10 MG Oral Tablet and Rivaroxaban 20 MG Oral Tablet in Postpartum, VTE Prophylaxis and VTE (Venous Thromboembolism), sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Thomas Jefferson University · Phase 1, Interventional, and Prevention
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.
The aim of our study is to perform a phase 1, single arm clinical trial to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic maternal doses. Our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. Our novel contributions to the existing body of literature will be in our investigation of rivaroxaban at both prophylactic and therapeutic doses, in repeated doses over time, and in a larger sample of participants. These results will provide physicians and national societies with safety data needed to properly counsel patients and advance clinical guidelines for postpartum care.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 10 is below the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Rivaroxaban 10 MG Oral Tablet
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.
Drug: Rivaroxaban 20 MG Oral Tablet
10mg rivaroxaban daily
Also known as: Xarelto
20mg rivaroxaban daily
Concentration of rivaroxaban in breast milk
Time/Concentration profile of rivaroxaban in breast milk prior to intake (0) and 3, 6, 12, 15 and 24 hours following morning dose on day 0-1
Time frame: Postpartum day 1
Concentration of rivaroxaban in breast milk
Time/concentration profile of rivaroxaban in breast milk 3 hours following morning dose on day 2 and onward
Time frame: Postpartum week 6
Absolute infant dose of rivaroxaban
The absolute infant dose is calculated from average drug concentrations in breast milk multiplied by an estimated breast milk intake of 150 mL/kg/day.
Time frame: 6 week postpartum
Relative infant dose
The relative infant dose is the absolute infant dose expressed as a percentage of the weight adjusted maternal dose, based on an average maternal weight of 75 kg. It is expressed in mg/kg/day.
Time frame: 6 weeks postpartum
Plan to share: No — The participant data will be kept confidential and access will be limited to the study investigators in order to respect the privacy of the participants.
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Studies of the drug tested here: Rivaroxaban