Registry of Efficacy and Safety of Non-vitamin K Antagonist Oral Anticoagulants for Thromboembolic Prevention in Patients with Congenital Heart Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009002
Sponsor Protocol Number: 17-009002
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.
More information
Publications
Publications are currently not available