Treatment and prevention of blood clots following the birth of a baby Pregnancy and Childbirth Treatment of venous thromboembolism during the post-partum period, prophylaxis of venous thromboembolism during the post-partum period
Conditions
Interventions
Volunteers will be assigned either rivaroxaban 20mg DAILY or edoxaban 60mg DAILY. They will be asked to take the medicine for 3 consecutive days and have their blood and breastmilk sampled. The sampli
Sponsors
King's Health Partners Clinical Trials Office
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/02/2024: 1. Subject is informed and given ample time and opportunity to think about her participation and has provided written informed consent for participation in the study before any study-specific procedures take place. 2. Subject is considered reliable and capable of adhering to applicable protocol requirements, including the study drug being administered orally and visit schedule according to the judgement of the Investigator. 3. Women are aged =18 years. 4. Within the 12-week postpartum period, with the final dose of the IMP being administered and sampled within 12 weeks post-partum. 5. Decision has been confirmed by the participant to hold breastfeeding their infant during the study period. 6. Negative pregnancy test. 7. Good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening. 8. Women have clinical laboratory test results within the reference ranges of the testing laboratory: normal renal and liver function, as judged by the chief investigator. 9. Women are not taking any medication interacting with edoxaban or rivaroxaban. 10. Women are available and permit the research team to make home visits to collect blood and milk samples. 11. Women agree to the study restrictions. Previous inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her participation and has provided written informed consent for participation in the study before any study-specific procedures take place. 2. Subject is considered reliable and capable of adhering to applicable protocol requirements, including the study drug being administered orally and visit schedule according to the judgement of the Investigator. 3. Women are aged =18 years. 4. Within the 8-week postpartum period, with the final dose of the IMP being administered and sampled within 8 weeks post-partum. 5. Decision has been confirmed by the participant to hold breastfeeding their infant during the study period. 6. Negative pregnancy test. 7. Good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening. 8. Women have clinical laboratory test results within the reference ranges of the testing laboratory: normal renal and liver function, as judged by the chief investigator. 9. Women are not taking any medication interacting with edoxaban or rivaroxaban. 10. Women are available and permit the research team to make home visits to collect blood and milk samples. 11. Women agree to the study restrictions.
Exclusion criteria
Exclusion criteria: 1. Women who are unable to provide written informed consent. 2. LMWH thromboprophylaxis is indicated. 3. Increased risk of bleeding for any reason. 4. Known contra-indications to edoxaban or rivaroxaban. 5. On-going treatment with aspirin, NSAIDs or other drugs that affect blood clotting. 6. Treatment with significant P-GP / CYP3A4 inducers or inhibitors. 7. Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat. 8. Known impaired renal function. 9. Known abnormal liver function tests. 10. Known hypersensitivity or allergy to edoxaban or rivaroxaban. 11. Use of other investigational study drugs within 7 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Edoxaban and rivaroxaban concentrations in plasma and breastmilk at the sampled time-points. Day 1: Time (hr) 3, 12, 24 Day 3: Time (hr) 0, 3, 12, 24, 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following PK parameters for edoxaban and rivaroxaban in milk and plasma will be computed: Area under the concentration-time curve (AUC) from zero to 24 hours (AUC(0-24)) on day 1 and day 3 for both breastmilk and maternal plasma. In addition Milk:Plasma ratio will be computed at day 1 and day 3. | — |
Countries
England, United Kingdom
Outcome results
None listed