check_circleStudy Completed
Deep Vein Thrombosis, Venous Thrombosis
Bayer Identifier:
15915
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Treatment of an acute deep vein thrombosis (DVT) with either rivaroxaban or current standard of care therapy
Trial purpose
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
5145Trial Dates
June 2012 - July 2015Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany | |
Completed | Many Locations, Switzerland | |
Completed | Many Locations, United Kingdom | |
Completed | Many Locations, France | |
Withdrawn | Many Locations, Poland | |
Completed | Many Locations, Italy | |
Completed | Many Locations, Spain | |
Completed | Many Locations, Belgium | |
Completed | Many Locations, Netherlands | |
Completed | Many Locations, Sweden | |
Completed | Many Locations, Denmark | |
Completed | Many Locations, Norway | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Israel | |
Completed | Many Locations, Portugal | |
Completed | Many Locations, Austria | |
Completed | Many Locations, Hungary | |
Completed | Many Locations, Greece | |
Withdrawn | Many Locations, Slovakia | |
Completed | Many Locations, Ukraine | |
Completed | Many Locations, Slovenia | |
Withdrawn | Many Locations, Ireland | |
Completed | Many Locations, Moldova | |
Completed | Many Locations, Canada |
Primary Outcome
- Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical sitedate_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionYesSafety Issue:
- Number of patients with symptomatic recurrent venous thromboembolic eventsdate_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionYesSafety Issue:
- All cause mortalitydate_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse cardiac events collectiondate_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionYesSafety Issue:
- Number of patients with other symptomatic thromboembolic eventsdate_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionYesSafety Issue:
- Treatment satisfaction (patient reported outcomes)date_rangeTime Frame:after approximately 2 years or 30 days after stop of therapyenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A