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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00808067




Registration number
NCT00808067
Ethics application status
Date submitted
12/12/2008
Date registered
15/12/2008
Date last updated
9/06/2014

Titles & IDs
Public title
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
Scientific title
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes
Secondary ID [1] 0 0
2008-005248-17
Secondary ID [2] 0 0
1160.71
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dabigatran dose 1
Treatment: Drugs - dabigatran dose 2

Experimental: dabigatran dose 1 - dabigatran high dose twice daily

Experimental: dabigatran dose 2 - dabigatran low dose twice daily


Treatment: Drugs: dabigatran dose 1
dabigatran high dose twice daily

Treatment: Drugs: dabigatran dose 2
dabigatran low dose twice daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Bleeding, Annualized Rate of Subjects With Major Bleeds - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Major bleeding must have satisfied one or more of the following criteria:
Bleeding associated with a reduction in hemoglobin of at least 20 g/L
Required transfusion of at least 2 units of blood or packed cells
Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal
Major bleed were classified as life-threatening if they met one or more of the following criteria:
Reduction in hemoglobin of at least 50 g/L
Transfusion of at least 4 units of blood or packed cells
Symptomatic intracranial bleeding, either subdural or intracerebral
Associated with hypotension requiring use of intravenous inotropic agents
Required surgical intervention to stop bleeding
Resulted in death
Timepoint [1] 0 0
up to 43 months
Secondary outcome [1] 0 0
Stroke, Annualized Rate of Subjects With Stroke - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Timepoint [1] 0 0
up to 43 months
Secondary outcome [2] 0 0
Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Timepoint [2] 0 0
up to 43 months
Secondary outcome [3] 0 0
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Pulmonary Embolism was generally documented by one of the following:
an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Timepoint [3] 0 0
up to 43 months
Secondary outcome [4] 0 0
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Timepoint [4] 0 0
up to 43 months
Secondary outcome [5] 0 0
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deep Vein Thrombosis (DVT) was generally documented by one of the following:
abnormal compression ultrasound (CUS),
an intraluminal filling defect on venography.
Timepoint [5] 0 0
up to 43 months
Secondary outcome [6] 0 0
Death, Annualized Rate of Subject Death - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Timepoint [6] 0 0
up to 43 months
Secondary outcome [7] 0 0
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [7] 0 0
up to 43 months
Secondary outcome [8] 0 0
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [8] 0 0
up to 43 months
Secondary outcome [9] 0 0
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [9] 0 0
up to 43 months
Secondary outcome [10] 0 0
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [10] 0 0
up to 43 months
Secondary outcome [11] 0 0
Annualized Rate of Subjects With Minor Bleeds - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Timepoint [11] 0 0
up to 43 months
Secondary outcome [12] 0 0
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [12] 0 0
up to 43 months
Secondary outcome [13] 0 0
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) - Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Timepoint [13] 0 0
up to 43 months

Eligibility
Key inclusion criteria
Inclusion criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed
consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
1160.71.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
1160.71.0510 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [3] 0 0
1160.71.0506 Boehringer Ingelheim Investigational Site - Milton
Recruitment hospital [4] 0 0
1160.71.0509 Boehringer Ingelheim Investigational Site - Ashford
Recruitment hospital [5] 0 0
1160.71.0507 Boehringer Ingelheim Investigational Site - Launceston
Recruitment hospital [6] 0 0
1160.71.0504 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [7] 0 0
1160.71.0501 Boehringer Ingelheim Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Milton
Recruitment postcode(s) [4] 0 0
- Ashford
Recruitment postcode(s) [5] 0 0
- Launceston
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Geelong
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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Nevada
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North Dakota
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Oklahoma
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Graz
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Linz
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Wien
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Sao Jose do Riio Preto
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Pleven
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Manitoba
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Nova Scotia
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Nantes
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Segre
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Germany
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Heidelberg
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Mannheim
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Witten
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Wuppertal
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Hungary
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India
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purposes of this study are:

1. To evaluate the long-term safety of dabigatran etexilate

2. To assess the effect of a knowledge translation intervention on patient outcomes
Trial website
https://clinicaltrials.gov/show/NCT00808067
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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

Summary results
Other publications