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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03488420
Other study ID # MHICC-2017-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 30, 2019
Est. completion date January 31, 2025

Study information

Verified date February 2024
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's discretion. Registry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic Case Report Form (eCRF). Data available in the patient's file will be collected. The only procedure to be performed in the context of this registry is the completion of questionnaires: the Montreal Cognitive Assessment (MoCA©) test and the Anti-Clot-Treatment Scale (ACTS-Q) questionnaire.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 133
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Edoxaban Pill
Subjects will be taking edoxaban 30 or 60 mg

Locations

Country Name City State
Canada CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby Granby Quebec
Canada CISSS de la Montérégie Centre Greenfield Park Quebec
Canada CISSS de Laval Laval Quebec
Canada Montreal Heart Institute Montréal Quebec
Canada IUCPQ Québec Quebec
Canada CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski Rimouski Quebec
Canada CISSS de Chaudière-Appalaches - Hopital Saint-Georges Saint-Georges Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec
Canada CIUSSS de la Mauricie-et-du-Centre-du-Québec Trois-Rivières Quebec

Sponsors (2)

Lead Sponsor Collaborator
Montreal Heart Institute Servier

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS) 2 years
Primary Cognitive function using the Montreal Cognitive Assessment (MoCA) test 2 years
Primary Compliance of subjects to edoxaban treatment 2 years
Primary Reasons for choosing edoxaban and reasons for the dosage 2 years
Primary Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria) 2 years
Primary Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE) 2 years
Primary Bleeding (Frequency, Location, Severity, Type of intervention and Outcome) 2 years
Primary Death (CV and non-CV) 2 years
Primary Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban 2 years
Primary Physician satisfaction with regards to edoxaban treatment 2 years
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