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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02596230
Registration number
NCT02596230
Ethics application status
Date submitted
28/10/2015
Date registered
4/11/2015
Date last updated
29/04/2020
Titles & IDs
Public title
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
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Scientific 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
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Secondary ID [1]
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1160.188
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective 1: Age
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Primary outcome [2]
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Objective 1: Sex
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Primary outcome [3]
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Objective 1: Index Event
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Primary outcome [4]
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Objective 1: Anticoagulant Treatment
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Primary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Primary outcome [6]
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Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
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Assessment method [6]
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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.
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Timepoint [6]
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12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Secondary outcome [1]
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Objective 2: Incidence Rate of Recurrent DVT and/or PE
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Assessment method [1]
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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.
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Timepoint [1]
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12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Secondary outcome [2]
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Objective 2: Incidence Rate of VTE-related Mortality
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Assessment method [2]
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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.
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Timepoint [2]
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12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Secondary outcome [3]
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Objective 2: Incidence Rate of All-cause Mortality
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Assessment method [3]
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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.
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Timepoint [3]
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12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2019
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Sample size
Target
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Accrual to date
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Final
7797
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Makati
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Quezon City
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Bydgoszcz
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Portugal
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Porto
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Portugal
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Russian Federation
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Ufa
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Nis
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Levice
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Martin
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Celje
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Rize
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United Arab Emirates
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Durham
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London
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North Shields
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02596230
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02596230
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