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

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ClinicalTrials.gov Identifier: NCT03488420
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : February 22, 2023
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
Montreal Heart Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation and Flutter Valvular Heart Disease Drug: Edoxaban Pill

Detailed 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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Groups and Cohorts
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Group/Cohort Intervention/treatment
Atrial Fibrillation and/or Atrial Flutter
Subjects taking edoxaban 30mg or 60 mg will be followed for 2 years. Subjects will perform the Montreal Cognitive Assessment (MoCA) Test at baseline and 1-year follow up. They will also answer the Anti-Clot Treatment questionnaire (ACTS-Q) at 1-year.
 Drug: Edoxaban Pill
Subjects will be taking edoxaban 30 or 60 mg
Other Names:
  • Lixiana
  • edoxaban tosylate monhydrate


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]
  2. Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS) [ Time Frame: 2 years ]
  3. Cognitive function using the Montreal Cognitive Assessment (MoCA) test [ Time Frame: 2 years ]
  4. Compliance of subjects to edoxaban treatment [ Time Frame: 2 years ]
  5. Reasons for choosing edoxaban and reasons for the dosage [ Time Frame: 2 years ]
  6. Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria) [ Time Frame: 2 years ]
  7. Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE) [ Time Frame: 2 years ]
  8. Bleeding (Frequency, Location, Severity, Type of intervention and Outcome) [ Time Frame: 2 years ]
  9. Death (CV and non-CV) [ Time Frame: 2 years ]
  10. Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban [ Time Frame: 2 years ]
  11. Physician satisfaction with regards to edoxaban treatment [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed or confirmed with Atrial Fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD) within the last 12 months, according to local standard procedures, judged by the investigator to be at risk of stroke and in whom anticoagulation with a NOAC drugs is clinically indicated and who are prescribed edoxaban.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488420


Locations
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Canada, Quebec
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, H1T 1C8
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, G5Y 4T8
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Québec
Trois-Rivières, Quebec, Canada
Sponsors and Collaborators
Montreal Heart Institute
Servier
Investigators
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Principal Investigator: Katia Dyrda, MD Montreal Heart Institute
More Information
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Additional Information:

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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03488420    
Other Study ID Numbers: MHICC-2017-001
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Heart Valve Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Edoxaban
 Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants