OCEA

Phase 1

• Conditions: Risk of stroke by atrial fibrillation; MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002353-38-BE
• Lead Sponsor: Ottawa Heart institute Research Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1284

Inclusion Criteria

1. Patient must be at least one year post-successful catheter ablation(s)
for atrial fibrillation without evidence of any clinically apparent
arrhythmia recurrence defined as all of the following:
No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent)
from 2-6 months after the last ablation,
AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after
6 months after the last ablation AND no AF/AT/AFL on at least 24 hour
Holter and ECG 2 months before enrolment in the study. The Holter/ECG
within 2 months of enrolment may also serve as the Holter performed 6
months or later after the last ablation - see section 2.3.1 for details.
2. Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients
in whom female sex or vascular disease are their sole risk factor may not
be enrolled.
3. Patient must be >18 years of age.
4. Patient must have non-valvular AF.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1002
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 282

Exclusion Criteria

1. Patient does not meet all of the above listed inclusion criteria.
2. Patient is unable or unwilling to provide informed consent.
3. Patient is included in another randomized clinical trial or a clinical trial
requiring an insurance.
4. Patient has been on an investigational drug within 30 days of
enrolment.
5. Patient has been on strong CYP3A inducers (such as rifampicin,
phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors
(such as ketoconazole or protease inhibitors) within 4 days of
enrolment.
6. Patient has creatinine clearance < 30 mL/min.
7. Patient has bleeding contra-indication to oral anticoagulation (such as
bleeding diathesis, hemorrhagic disorder, significant gastrointestinal
bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding
history, fibrinolysis within 48 hours of enrollment).
8. Patient has other contraindication to oral anticoagulation or treatment
with antiplatelet agent (such as allergy).
9. Patient has a contraindication to magnetic resonance imaging (MRI)
or is unlikely to tolerate due to severe claustrophobia.
10. Patients with a contraindication to implantation of an implantable
loop recorder if the patient opts for loop recorder as part of the
study(such as limited immunocompetence or a wound healing
disorder).
11. Patient has valvular atrial fibrillation [reference AHA guidelines].
12. Patient has a non-arrhythmic condition necessitating long-term oral
anticoagulation.
13. Patient had a severe, disabling stroke within one year prior to
enrollment or any stroke within 14 days of enrollment.
14. Patient with special risk factors for stroke unrelated to AF,
specifically known thrombophilia/ hypercoagulability, uncontrolled
hypertension (systolic blood pressure >180 mmHg and/or diastolic
blood pressure >100 mmHg within 4 days of enrollment), untreated
familial hyperlipidemia, known vascular anomaly (intracranial
aneurysm/ arteriovenous malformation or chronic vascular dissection),
or known severe carotid disease.
15. Pregnancy or breastfeeding.
16. Women of childbearing age who refuse to use a highly effective and
medically acceptable form of contraception throughout the study.
17. Patients who are > 85 years of age.
18. Patients who are critically ill or who have a life expectancy <3 years.
19. Patients for whom the investigator believes that the trial is not in
the interest of the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified