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

Completed

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT02596230

Run by

Boehringer Ingelheim

People needed

7797

Starts

2015-11-05

Expected to finish

2019-03-31

Last updated by the study team

2020-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Health and Life Research Institute, LLC — Miami, Florida, United States
• Med-Care Research — Miami, Florida, United States
• Pines Care Research Center — Pembroke Pines, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Ellipsis Group — Atlanta, Georgia, United States
• Wellstar Cardiovascular Medicine — Marietta, Georgia, United States
• Fox Valley Clinical Research Center, LLC — Aurora, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• University Of Mississippi Medical Center — Jackson, Mississippi, United States
• Vidant Multispecialty Clnc Kinston — Kinston, North Carolina, United States
• Sanford Cardiology — Sanford, North Carolina, United States
• Lycoming Internal Medicine, Inc — Jersey Shore, Pennsylvania, United States
• Research Associates of Jackson — Jackson, Tennessee, United States
• The University Of Texas at Houston — Houston, Texas, United States
• Cardiology Center of Houston, PA — Katy, Texas, United States
• Cardio Voyage — McKinney, Texas, United States
• Waukesha Heart Institute — Waukesha, Wisconsin, United States
• Hospital Universitario Austral — Buenos Aires, Argentina
• Hospital Aleman — CABA, Argentina
• Hospital Italiano — CABA, Argentina
• ICBA — CABA, Argentina
• Clinica Juncal — Temperley, Argentina
• LKH Feldkirch — Feldkirch, Austria
• Cardiovascular Innovation and Research Center — Long Beach, California, United States

Full record on ClinicalTrials.gov

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