RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
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Details and patient eligibility
About
RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Written informed consent provided by the patient in accordance with local regulations
- Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)
- Age >= 18 years
- For Objective 2, the planned anticoagulation therapy should be for at least 3 months
- For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection
Exclusion criteria
- Need for anticoagulation therapy for conditions other than venous thromboembolism (VTE)
- Current participation in a clinical trial for VTE indication or current use of an unapproved drug
Trial design
7,797 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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