Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)

ID
Name
MHICC-2017-001
Description
The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.
Trial arms
Trial start
2019-04-30
Estimated PCD
2025-01-31
Trial end
2025-01-31
Status
Active (not recruiting)
Treatment
Edoxaban Pill
Subjects will be taking edoxaban 30 or 60 mg
Arms:
Atrial Fibrillation and/or Atrial Flutter
Other names:
Lixiana, edoxaban tosylate monhydrate
Size
133
Primary endpoint
Characterization of patients with diagnosed or confirmed atrial fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD), within the last 12 months
2 years
Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
2 years
Cognitive function using the Montreal Cognitive Assessment (MoCA) test
2 years
Compliance of subjects to edoxaban treatment
2 years
Reasons for choosing edoxaban and reasons for the dosage
2 years
Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
2 years
Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
2 years
Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
2 years
Death (CV and non-CV)
2 years
Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
2 years
Physician satisfaction with regards to edoxaban treatment
2 years
Eligibility criteria
Inclusion Criteria: 1. Male and female patients aged ≥ 18 years at baseline (signing of consent); 2. Willing and able to provide written informed consent; 3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form; 4. Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months; 5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban. Exclusion Criteria: 1. Patients with AF and/or AFL secondary to reversible cause; 2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis; 3. Patients planned to have an intervention for valvular heart disease in the next 12 months; 4. Pregnant or breastfeeding women. 5. Short term anticoagulation post cardioversion or ablation.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 133, 'type': 'ACTUAL'}}
Updated at
2024-02-26

1 organization

1 product

2 indications

Organization
Montreal Heart Institute
Product
Edoxaban
Indication
Atrial Fibrillation
Indication
Valvular Heart Disease