drugset / Trial / NCT07658989

Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves

NCT07658989

Recruiting 100 enrolled Mount Sinai Hospital, Canada
Non-randomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2026-05-26
Primary completion
2030-01
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg
Subject Dalteparin sodium Other / unclassified 135 iu/kg
Subject Enoxaparin sodium Other / unclassified 1.35 iu/kg
Subject Warfarin Small molecule