Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
Recruiting now · Not applicable
Conditions studied: Pregnancy, Prosthetic Heart Valve, Anticoagulant Therapy
In brief
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.
Key facts
- Study ID
- NCT07658989
- Run by
- Mount Sinai Hospital, Canada
- People needed
- 100
- Starts
- 2026-05-26
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant individuals with one or more MHVs
- Who consent to participate
- Are 18 years or older and
- Less than 12 weeks gestation
You may not qualify if…
- 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
Where it is running
- Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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