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

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
Registration Number
NCT00808067
Lead Sponsor
Boehringer Ingelheim
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5897
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
dabigatran dose 2dabigatran dose 2dabigatran low dose twice daily
dabigatran dose 1dabigatran dose 1dabigatran high dose twice daily
Primary Outcome Measures
NameTimeMethod
Major Bleeding, Annualized Rate of Subjects With Major Bleedsup 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
NameTimeMethod
Stroke, Annualized Rate of Subjects With Strokeup 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

Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEEup 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.

Pulmonary Embolism (PE), Annualized Rate of Subjects With PEup 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.

Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MIup 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.

Deep Vein Thrombosis, Annualized Rate of Subjects With DVTup 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.

Death, Annualized Rate of Subject Deathup 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.

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)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.

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Deathup 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.

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Deathup 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.

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 Bleedup 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.

Annualized Rate of Subjects With Minor Bleedsup 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.

Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)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.

Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)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.

Trial Locations

Locations (567)

1160.71.0046 Boehringer Ingelheim Investigational Site

🇺🇸

Birmingham, Alabama, United States

1160.71.0057 Boehringer Ingelheim Investigational Site

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Birmingham, Alabama, United States

1160.71.0211 Boehringer Ingelheim Investigational Site

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Birmingham, Alabama, United States

1160.71.0115 Boehringer Ingelheim Investigational Site

🇺🇸

Mobile, Alabama, United States

1160.71.0104 Boehringer Ingelheim Investigational Site

🇺🇸

Lake Havasu City, Arizona, United States

1160.71.0185 Boehringer Ingelheim Investigational Site

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Tucson, Arizona, United States

1160.71.0038 Boehringer Ingelheim Investigational Site

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Hot Springs, Arkansas, United States

1160.71.0302 Boehringer Ingelheim Investigational Site

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Jonesboro, Arkansas, United States

1160.71.0191 Boehringer Ingelheim Investigational Site

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Little Rock, Arkansas, United States

1160.71.0213 Boehringer Ingelheim Investigational Site

🇺🇸

Little Rock, Arkansas, United States

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1160.71.0046 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States

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