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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02168829




Registration number
NCT02168829
Ethics application status
Date submitted
18/06/2014
Date registered
20/06/2014

Titles & IDs
Public title
Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
Scientific title
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
Secondary ID [1] 0 0
327494
Universal Trial Number (UTN)
Trial acronym
OCEAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Rivaroxaban - Rivaroxaban 15 mg daily

Active comparator: Acetylsalicylic acid (ASA) - ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Clinical, overt stroke
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Incidence of one or more covert MRI stroke(s) >15 mm
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Composite of all major and minor bleeding
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Major bleeding only
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Minor bleeding only
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Intracranial hemorrhage
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Transient ischemic attack
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
All-cause mortality
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events.
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Occurrence of non-primary endpoint MRI changes from baseline to final scan
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
Neuropsychological testing
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Health economics
Timepoint [12] 0 0
3 years

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 a 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
1284
Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
The Alfred Melbourne - Melbourne
Recruitment hospital [4] 0 0
Melbourne Health - Melbourne
Recruitment hospital [5] 0 0
Heart Rhythm Clinic - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerp
Country [3] 0 0
Belgium
State/province [3] 0 0
Arlon
Country [4] 0 0
Belgium
State/province [4] 0 0
Bonheiden
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussel
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Ghent
Country [10] 0 0
Belgium
State/province [10] 0 0
Hasselt
Country [11] 0 0
Belgium
State/province [11] 0 0
Lanaken
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Belgium
State/province [14] 0 0
Roeselare
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Nova Scotia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Kelowna
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
Germany
State/province [22] 0 0
Bayern
Country [23] 0 0
Germany
State/province [23] 0 0
Hessen
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Schleswig-Holstein
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Israel
State/province [28] 0 0
Nahariya

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Heart Institute Research Corporation
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Biotronik Canada Inc
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Atul Verma, MD
Address 0 0
Southlake Regional Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02168829