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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
up to 43 months
Secondary outcome [1] 0 0
Stroke, Annualized Rate of Subjects With Stroke
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
Timepoint [2] 0 0
up to 43 months
Secondary outcome [3] 0 0
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
Timepoint [3] 0 0
up to 43 months
Secondary outcome [4] 0 0
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
Timepoint [4] 0 0
up to 43 months
Secondary outcome [5] 0 0
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
Timepoint [5] 0 0
up to 43 months
Secondary outcome [6] 0 0
Death, Annualized Rate of Subject Death
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)
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
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
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
Timepoint [10] 0 0
up to 43 months
Secondary outcome [11] 0 0
Annualized Rate of Subjects With Minor Bleeds
Timepoint [11] 0 0
up to 43 months
Secondary outcome [12] 0 0
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
Timepoint [12] 0 0
up to 43 months
Secondary outcome [13] 0 0
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
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
Sex
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
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
5897
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
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- 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
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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/study/NCT00808067
Trial related presentations / publications
Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00808067