NCT07658989 Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
| NCT ID | NCT07658989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-05-26 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07658989 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07658989 currently recruiting?
Yes, NCT07658989 is actively recruiting participants. Contact the research team at nadine.shehata@sinaihealth.ca for enrollment information.
Where is the NCT07658989 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07658989 clinical trial?
NCT07658989 is sponsored by Mount Sinai Hospital, Canada. The trial plans to enroll 100 participants.