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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596230
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : April 29, 2020
Last Update Posted : April 29, 2020
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

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Study Type : Observational
Actual Enrollment : 7797 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
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

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. Objective 1: Age [ Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.

    The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.


  2. Objective 1: Sex [ Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Sex of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.

    The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.


  3. Objective 1: Index Event [ Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Type of index event (e.g., DVT or PE or DVT and PE) diagnosed at the time of acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.

    The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.


  4. Objective 1: Anticoagulant Treatment [ Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Type of treatment received following acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.

    The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.


  5. Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs) [ Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Incidence rate of ISTH (International Society on Thrombosis and Haemostasis) major bleeding and CRNMB (clinically relevant non major bleeding) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.

    For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.


  6. Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality [ Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Incidence rate of Symptomatic Recurrent VTE (Venous Thromboembolism) including VTE related mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.

    For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.



Secondary Outcome Measures :
  1. Objective 2: Incidence Rate of Recurrent DVT and/or PE [ Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Incidence rate of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.

    For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.


  2. Objective 2: Incidence Rate of VTE-related Mortality [ Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Incidence rate of VTE-related Mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.

    For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.


  3. Objective 2: Incidence Rate of All-cause Mortality [ Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). ]

    Incidence rate of all-cause mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.

    For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.




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


Locations
Show Show 222 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] April 5, 2017
Study Protocol  [PDF] November 16, 2016

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02596230    
Other Study ID Numbers: 1160.188
First Posted: November 4, 2015    Key Record Dates
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases