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RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00808067
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : April 8, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: dabigatran dose 1 Drug: dabigatran dose 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : November 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: dabigatran dose 1
dabigatran high dose twice daily
 Drug: dabigatran dose 1
dabigatran high dose twice daily
Experimental: dabigatran dose 2
dabigatran low dose twice daily
 Drug: dabigatran dose 2
dabigatran low dose twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Major Bleeding, Annualized Rate of Subjects With Major Bleeds [ Time Frame: up to 43 months ]

    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


Secondary Outcome Measures :
  1. Stroke, Annualized Rate of Subjects With Stroke [ Time Frame: up to 43 months ]

    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


  2. Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE [ Time Frame: up to 43 months ]

    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.


  3. Pulmonary Embolism (PE), Annualized Rate of Subjects With PE [ Time Frame: up to 43 months ]

    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:

    1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
    2. 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
    3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
    4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.

  4. Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI [ Time Frame: up to 43 months ]

    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.


  5. Deep Vein Thrombosis, Annualized Rate of Subjects With DVT [ Time Frame: up to 43 months ]

    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:

    1. abnormal compression ultrasound (CUS),
    2. an intraluminal filling defect on venography.

  6. Death, Annualized Rate of Subject Death [ Time Frame: up to 43 months ]

    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.


  7. Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) [ Time Frame: up to 43 months ]
    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.

  8. Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death [ Time Frame: up to 43 months ]
    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.

  9. Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death [ Time Frame: up to 43 months ]
    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.

  10. 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 [ Time Frame: up to 43 months ]
    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.

  11. Annualized Rate of Subjects With Minor Bleeds [ Time Frame: up to 43 months ]

    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.


  12. Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) [ Time Frame: up to 43 months ]
    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.

  13. Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) [ Time Frame: up to 43 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed consent

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY

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): NCT00808067


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00808067    
Other Study ID Numbers: 1160.71
2008-005248-17 ( EudraCT Number: EudraCT )
First Posted: December 15, 2008    Key Record Dates
Results First Posted: April 8, 2014
Last Update Posted: June 9, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants