Center for Global Research Data

Using Dabigatran etexilate to prevent blood clots in women after childbirth

Lead Investigator: Paul Ayuk, Newcastle-upon-Tyne Hospitals NHS Trust
Title of Proposal Research: Using Dabigatran etexilate to prevent blood clots in women after childbirth
Vivli Data Request: 7777
Funding Source: Funding application planned for Efficacy and Mechanism Evaluation (NIHR – UK)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Every year in England, ~ 25,000 people develop blood clots in their veins while in hospital that result in death. The prevention of such deaths is an essential part of hospital care. Pregnant women are at increased risk of developing such blood clots, and this risk is highest after they have given birth. In all other medical specialties, the prevention of these blood clots has been revolutionised by the introduction of tablet medicines called direct oral anti-coagulants (DOACs). However, the only way to prevent these blood clots in women who have just given birth is to administer injections every day with a drug called low molecular weight heparin (LMWH). We know that the new tablet treatments (DOACs) are better and cheaper than injections with LMWH. Furthermore, mothers have told us of the adverse impact that self-injection with LMWH has on their mental and physical health at a time when they have a new-born baby, and their concerns about the plastic waste that comes with the injections. The new tablet treatments are not offered to women who have just given birth because we do not know if the medicines will get into breast milk and possibly harm the breast-fed baby. We have some early data to show that one of these new oral treatments (called dabigatran etexilate) will not get into breast milk if new mothers are given the medicine to prevent blood clots. This research proposal aims to extend this work by studying more women and then compare the benefits, risks and costs of dabigatran etexilate tablets to those of injections of LMWH. As part of this wider objective, we wish to use data from research already undertaken by Boehringer-Ingelheim in non-pregnant patients and healthy volunteers as controls for the data we will obtain from pregnant women. The data from Boehringer-Ingelheim studies will also help us calculate the number of pregnant women that we will need to study.

Requested Studies:

Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I
Data Contributor: Boehringer Ingelheim
Study ID: NCT02170701
Sponsor ID: 1160.11

BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Data Contributor: Boehringer Ingelheim
Study ID: NCT01225822
Sponsor ID: 1160.19

Dose Exploration in Patients With Atrial Fibrillation
Data Contributor: Boehringer Ingelheim
Study ID: NCT01227629
Sponsor ID: 1160.20

Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
Data Contributor: Boehringer Ingelheim
Study ID: NCT01136408
Sponsor ID: 1160.49

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00262600
Sponsor ID: 1160.26

Ayuk, P., Kampouraki, E., Truemann, A., Sidgwick, F., McDonald, L., Bingham, J., Murphy, P. and Kamali, F. (2020), Investigation of dabigatran secretion into breast milk: Implications for oral thromboprophylaxis in post-partum women. Am J Hematol, 95: E10-E13. https://doi.org/10.1002/ajh.25652 This study contains dabigatran concentrations in plasma and breast milk in 2 participants. We will use these data as ‘experimental data’ while the data provided by Boehringer-Ingelheim would serve as ‘controls’. These data will be analysed as per analysis plan.
Data Contributor: I WILL BRING MY OWN