Registry of Efficacy and Safety of Non-vitamin K Antagonist Oral Anticoagulants for Thromboembolic Prevention in Patients with Congenital Heart Disease

Overview

About this study

The purpose of this study is to explore the potential role of NOAC as an alternative therapy in the congenital heart disease population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

All ACHD patients (age ≥ 18 years old) followed at Mayo Clinic Rochester, Minnesota who are already on NOACs for clinical indications such as:

Nonvalvular atrial arrhythmia’s (no mechanical valves or severe mitral stenosis)
Prevention of thrombotic complications after an acute coronary syndrome in combination with acetylsalicylate and/or clopidogrel
Treatment or secondary prevention of deep venous thrombosis and pulmonary embolism

Exclusion Criteria:

Significantly elevated risk of bleeding, including vascular malformations, recent ulcerative gastrointestinal disease, recent surgery to central nervous system and recent or active major bleedings.
Current malignancy
Impaired liver function defined as liver function tests assay>3x the upper limit of normal (ULN) and/or coagulopathy.
Impaired renal function, with glomerular filtration rate (GFR) <15 ml/min/1.73m2 (or <30 for dabigatran)
Pregnancy or lactation
Age <18 years

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Alexander Egbe, M.B.B.S., M.P.H.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Egbe, M.B.B.S., M.P.H.

Closed for enrollment

More information

Publications

Publications are currently not available

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