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Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves

RecruitingNAAges 18 Years - 45 YearsFemaleMount Sinai Hospital, Canada
NCT07658989 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Pregnant individuals with one or more MHVs 2. Who consent to participate 3. Are 18 years or older and 4. Less than 12 weeks gestation Exclusion Criteria: 1. Have a platelet count less than 50 x 10(9)/L as there is an increased risk of bleeding with thrombocytopenia, and/or 2. Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g/L or in hemodynamic instability. 3. Have new valve thrombosis identified immediately prior to pregnancy
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What it tests

  • LMWH and LDA
  • Vitamin K antagonists (e.g warfarin)+/- LDA
  • Sequential therapy +/- LDA
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Where

1 site
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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