RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism



Status:Active, not recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:November 5, 2015
End Date:February 28, 2019

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Characterization of Patients Following Acute Venous Thromboembolism (VTE) and Safety and Effectiveness of Dabigatran Etexilate (DE) in the Treatment and Secondary Prevention of Acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Comparison to Vitamin K Antagonist (VKA) in Routine Clinical Practice - RE-COVERY DVT/PE

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.


Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations

2. 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)

3. Age >= 18 years

4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months

5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for
follow-up data collection

Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism
(VTE)

2. Current participation in a clinical trial for VTE indication or current use of an
unapproved drug
We found this trial at
20
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Atlanta, Georgia 30342
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Buenos Aires,
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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Houston, Texas 77030
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Jackson, Tennessee 38301
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Jersey Shore, Pennsylvania 17740
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Katy, Texas 77450
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Kinston, North Carolina 28501
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Long Beach, California 90813
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55 Whitcher Street
Marietta, Georgia 30060
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McKinney, Texas 75071
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Miami, Florida 33165
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Pembroke Pines, Florida 33026
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Sanford, North Carolina 27330
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Waukesha, Wisconsin 53188
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