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

This study is currently recruiting participants.
Verified October 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02596230
First Posted: November 4, 2015
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Demographic information (age) for Objective 1 patients [ Time Frame: baseline ]
  • Demographic information (gender) for Objective 1 patients [ Time Frame: baseline ]
  • International Society of Thrombosis and Haemostasis (ISTH) Major bleeding and ISTH clinically relevant non major bleeding (CRNMB) in Objective 2 patients [ Time Frame: 12 months ]
  • symptomatic recurrent VTE including VTE-related mortality in Objective 2 patients [ Time Frame: 12 months ]
  • Anticoagulation treatment choice for VTE for Objective 1 patients [ Time Frame: baseline ]
  • Venous thromboembolism (VTE) presentation at baseline for Objective 1 patients [ Time Frame: baseline ]

Secondary Outcome Measures:
  • Recurrent DVT and PE in Objective 2 patients [ Time Frame: 12 months ]
  • VTE-related mortality in Objective 2 patients [ Time Frame: 12 months ]
  • all-cause mortality in Objective 2 patients [ Time Frame: 12 months ]
  • Recurrent deep vein thrombosis (DVT) in Objective 2 patients [ Time Frame: 12 months ]
  • Recurrent pulmonary embolism (PE) in Objective 2 patients [ Time Frame: 12 months ]

Estimated Enrollment: 14000
Actual Study Start Date: November 5, 2015
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with acute VTE
Patients will be enrolled for cross sectional characterization of baseline characteristics
Dabigatran
Patients treated with dabigatran for acute VTE will be followed for one year
vitamin K antagonist
Patients treated with VKA for acute VTE will be followed for one year

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute venous thromboembolism
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596230


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Ellipsis Group Recruiting
Atlanta, Georgia, United States, 30342
United States, Texas
The University Of Texas at Houston Recruiting
Houston, Texas, United States, 77030
Belgium
CHU Charleroi Recruiting
Charleroi, Belgium, 6000
H.-Hartziekenhuis Recruiting
Lier, Belgium, 2500
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Italy
Spedali Riuniti di Livorno Recruiting
Livorno, Italy, 57124
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang-si, Korea, Republic of, 14068
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of, 42472
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Soon Chun Hyang University Hospital Seoul Recruiting
Seoul, Korea, Republic of, 04401
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Slovakia
VASA-CARE, s.r.o. Recruiting
Trnava, Slovakia, 917 01
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02596230     History of Changes
Other Study ID Numbers: 1160.188
First Submitted: October 28, 2015
First Posted: November 4, 2015
Last Update Posted: October 19, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
Vitamin K
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs