Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMount Sinai Hospital, Canada
About this trial
The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to warfarin/vitamin K antagonist (VKA) to reduce the chance of clotting around the mechanical valve and improve survival. The study is a pilot study as the study investigators need to ensure that the blood levels needed for adequate amounts of LMWH and warfarin can be maintained during pregnancy to be able to compare LMWH and aspirin to warfarin. If this study shows that we can collect the tests that are needed for a larger study, the individuals' information who participated in this pilot study will be moved to the larger study. The larger study will compare survival, clot development and cardiac function as well as safety of these two common blood thinners.
Eligibility criteria
Qualifiers
Pregnant individuals with one or more MHVs
Who consent to participate
Are 18 years or older and
Less than 12 weeks gestation
Disqualifiers
Have a platelet count less than 50 x 10(9)/L as there is an increased risk of bleeding with thrombocytopenia, and/or
Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g/L or in hemodynamic instability.
Have new valve thrombosis identified immediately prior to pregnancy
Trial design
Treatments tested in this trial
- LMWH and LDA
- Vitamin K antagonists (e.g warfarin)+/- LDA
- Sequential therapy +/- LDA
Treatment groups
100 Participants
are divided into 3 treatment groupsLocations
1Mount Sinai HospitalM5G1X5, TorontoOntario, Canada
Sponsors and collaborators
Mount Sinai Hospital, Canada
Lead sponsor
Source ClinicalTrials.gov