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

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

sites

University of Mississippi Medical Center

2500 N State St
Jackson, Mississippi 39216

(601) 984-1000