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

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ClinicalTrials.gov Identifier: NCT02596230
Recruitment Status : Active, not recruiting
First Posted : November 4, 2015
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease
Venous Thromboembolism

Study Type : Observational
Estimated Enrollment : 14000 participants
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
Actual Study Start Date : November 5, 2015
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Dabigatran

Group/Cohort
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



Primary Outcome Measures :
  1. Demographic information (age) for Objective 1 patients [ Time Frame: baseline ]
  2. Demographic information (gender) for Objective 1 patients [ Time Frame: baseline ]
  3. 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 ]
  4. symptomatic recurrent VTE including VTE-related mortality in Objective 2 patients [ Time Frame: 12 months ]
  5. Anticoagulation treatment choice for VTE for Objective 1 patients [ Time Frame: baseline ]
  6. Venous thromboembolism (VTE) presentation at baseline for Objective 1 patients [ Time Frame: baseline ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


  Show 89 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02596230     History of Changes
Other Study ID Numbers: 1160.188
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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