The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,353
dabigatran etexilate capsules 150 mg BID
Matching placebo BID
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time frame: 6 months
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time frame: 6 months
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Time frame: 6 months
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Time frame: 6 months
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Time frame: 6 months
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1160.63.01025 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1160.63.01023 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
1160.63.01002 Boehringer Ingelheim Investigational Site
Laguna Hills, California, United States
1160.63.01014 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1160.63.01003 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1160.63.01030 Boehringer Ingelheim Investigational Site
Key West, Florida, United States
1160.63.01022 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
1160.63.01044 Boehringer Ingelheim Investigational Site
New Iberia, Louisiana, United States
1160.63.01017 Boehringer Ingelheim Investigational Site
Biddeford, Maine, United States
1160.63.01004 Boehringer Ingelheim Investigational Site
Salisbury, Maryland, United States
...and 137 more locations
Centrally Confirmed Bleeding Event During the Treatment Period
Major bleeding events (MBE) had to fulfil at least 1 of the following criteria: * Fatal bleeding * Associated with a fall in haemoglobin of ≥2 g/dL * Led to the transfusion of ≥2 units packed cells or whole blood * Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Examples of these bleedings were: * Bleeding that compromised haemodynamics * Bleeding that led to hospitalisation Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs. All bleeding events include MBEs, CRBEs, and trivial bleeding events.
Time frame: 6 months
Centrally Confirmed Cardiovascular Events During the Treatment Period
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Time frame: 6 months
Laboratory Measures, Especially Liver Function Tests (LFTs)
Number of participants with possible clinically significant abnormalities during the treatment period.
Time frame: 6 months