Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00808067
First received: December 12, 2008
Last updated: June 3, 2014
Last verified: March 2014

December 12, 2008
June 3, 2014
November 2008
December 2012   (final data collection date for primary outcome measure)
Major Bleeding, Annualized Rate of Subjects With Major Bleeds [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

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
Since the objective of this trial is safety, there are no primary efficacy endpoints. Safety will primarily be determined by the occurence of major bleeding. [ Time Frame: up to 28 months ]
Complete list of historical versions of study NCT00808067 on ClinicalTrials.gov Archive Site
  • Stroke, Annualized Rate of Subjects With Stroke [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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

  • Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.

  • Pulmonary Embolism (PE), Annualized Rate of Subjects With PE [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.
  • Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.

  • Deep Vein Thrombosis, Annualized Rate of Subjects With DVT [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.
  • Death, Annualized Rate of Subject Death [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.

  • Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
    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.
  • Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Annualized Rate of Subjects With Minor Bleeds [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]

    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.

  • Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
    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.
  • Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
    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.
The secondary endpoint is the individual and composite incidence of stroke, non CNS systemic embolism, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and all deaths. [ Time Frame: up to 28 months ]
Not Provided
Not Provided
 
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: dabigatran dose 1
    dabigatran high dose twice daily
  • Drug: dabigatran dose 2
    dabigatran low dose twice daily
  • Experimental: dabigatran dose 1
    dabigatran high dose twice daily
    Intervention: Drug: dabigatran dose 1
  • Experimental: dabigatran dose 2
    dabigatran low dose twice daily
    Intervention: Drug: dabigatran dose 2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5897
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

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

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
 
NCT00808067
1160.71, 2008-005248-17
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP