Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02596230
Registration number
NCT02596230
Ethics application status
Date submitted
28/10/2015
Date registered
4/11/2015
Titles & IDs
Public title
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
Query!
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
Query!
Secondary ID [1]
0
0
1160.188
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Objective 1: Age
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Primary outcome [2]
0
0
Objective 1: Sex
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Primary outcome [3]
0
0
Objective 1: Index Event
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Primary outcome [4]
0
0
Objective 1: Anticoagulant Treatment
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Primary outcome [5]
0
0
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)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Primary outcome [6]
0
0
Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Secondary outcome [1]
0
0
Objective 2: Incidence Rate of Recurrent DVT and/or PE
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Secondary outcome [2]
0
0
Objective 2: Incidence Rate of VTE-related Mortality
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
Secondary outcome [3]
0
0
Objective 2: Incidence Rate of All-cause Mortality
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/11/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/03/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
7797
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Tennessee
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Wisconsin
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Buenos Aires
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Caba
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Temperley
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Feldkirch
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Graz
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Innsbruck
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Bruxelles
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Charleroi
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Lier
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Liège
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Belo Horizonte
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Campinas
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
São Paulo
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Plovdiv
Query!
Country [27]
0
0
Bulgaria
Query!
State/province [27]
0
0
Sofia
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Stara Zagora
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Ontario
Query!
Country [30]
0
0
Chile
Query!
State/province [30]
0
0
Santiago
Query!
Country [31]
0
0
Colombia
Query!
State/province [31]
0
0
Armenia
Query!
Country [32]
0
0
Colombia
Query!
State/province [32]
0
0
Cali
Query!
Country [33]
0
0
Colombia
Query!
State/province [33]
0
0
Cartagena
Query!
Country [34]
0
0
Colombia
Query!
State/province [34]
0
0
Manizales
Query!
Country [35]
0
0
Colombia
Query!
State/province [35]
0
0
Medellin
Query!
Country [36]
0
0
Czechia
Query!
State/province [36]
0
0
Beroun
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Brno
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Hodonin
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Louny
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Mlada Boleslav
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Nachod
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Olomouc
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Plzen
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Praha 2
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Praha 4
Query!
Country [46]
0
0
Egypt
Query!
State/province [46]
0
0
Alexandria
Query!
Country [47]
0
0
Egypt
Query!
State/province [47]
0
0
Cairo
Query!
Country [48]
0
0
Egypt
Query!
State/province [48]
0
0
Kalyoub
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Berlin
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Dresden
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Goerlitz
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Greifswald
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Heidelberg
Query!
Country [54]
0
0
Greece
Query!
State/province [54]
0
0
Alexandroupolis
Query!
Country [55]
0
0
Greece
Query!
State/province [55]
0
0
Athens
Query!
Country [56]
0
0
Greece
Query!
State/province [56]
0
0
Ioannina
Query!
Country [57]
0
0
Greece
Query!
State/province [57]
0
0
Larissa
Query!
Country [58]
0
0
Greece
Query!
State/province [58]
0
0
Thessaloniki
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Balassagyarmat
Query!
Country [60]
0
0
Hungary
Query!
State/province [60]
0
0
Budapest
Query!
Country [61]
0
0
Hungary
Query!
State/province [61]
0
0
Debrecen
Query!
Country [62]
0
0
Hungary
Query!
State/province [62]
0
0
Kistarcsa
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Nagykanizsa
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Pecs
Query!
Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Szentes
Query!
Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Szolnok
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Acerra
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Alba
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Bari
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Castelfranco Veneto
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Faenza (RA)
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Lecce
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Livorno
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Macerata
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Napoli
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Ortona (CH)
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Palermo
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Roma
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Sassari
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Varese
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Vimercate (Mi)
Query!
Country [82]
0
0
Korea, Republic of
Query!
State/province [82]
0
0
Anyang-si
Query!
Country [83]
0
0
Korea, Republic of
Query!
State/province [83]
0
0
Busan
Query!
Country [84]
0
0
Korea, Republic of
Query!
State/province [84]
0
0
Daegu
Query!
Country [85]
0
0
Korea, Republic of
Query!
State/province [85]
0
0
Seoul
Query!
Country [86]
0
0
Latvia
Query!
State/province [86]
0
0
Daugavpils
Query!
Country [87]
0
0
Latvia
Query!
State/province [87]
0
0
Liepaja
Query!
Country [88]
0
0
Latvia
Query!
State/province [88]
0
0
Riga
Query!
Country [89]
0
0
Latvia
Query!
State/province [89]
0
0
Talsi
Query!
Country [90]
0
0
Latvia
Query!
State/province [90]
0
0
Ventspils
Query!
Country [91]
0
0
Lebanon
Query!
State/province [91]
0
0
Beirut
Query!
Country [92]
0
0
Lebanon
Query!
State/province [92]
0
0
El-Chouf
Query!
Country [93]
0
0
Lebanon
Query!
State/province [93]
0
0
Jbeil
Query!
Country [94]
0
0
Lebanon
Query!
State/province [94]
0
0
Saida
Query!
Country [95]
0
0
Malaysia
Query!
State/province [95]
0
0
Kota Bahru
Query!
Country [96]
0
0
Malaysia
Query!
State/province [96]
0
0
Kuala Lumpur
Query!
Country [97]
0
0
Mexico
Query!
State/province [97]
0
0
Guadalajara
Query!
Country [98]
0
0
Mexico
Query!
State/province [98]
0
0
San Luis Potosí
Query!
Country [99]
0
0
Mexico
Query!
State/province [99]
0
0
Veracruz
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Amsterdam
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
Breda
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Nieuwegein
Query!
Country [103]
0
0
Netherlands
Query!
State/province [103]
0
0
Tilburg
Query!
Country [104]
0
0
New Zealand
Query!
State/province [104]
0
0
Palmerston North
Query!
Country [105]
0
0
Peru
Query!
State/province [105]
0
0
Piura
Query!
Country [106]
0
0
Philippines
Query!
State/province [106]
0
0
Makati
Query!
Country [107]
0
0
Philippines
Query!
State/province [107]
0
0
Manila, Philippines
Query!
Country [108]
0
0
Philippines
Query!
State/province [108]
0
0
Quezon City
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Bydgoszcz
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Bytom
Query!
Country [111]
0
0
Poland
Query!
State/province [111]
0
0
Ostroleka
Query!
Country [112]
0
0
Poland
Query!
State/province [112]
0
0
Wroclaw
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Ponta Delgada
Query!
Country [114]
0
0
Portugal
Query!
State/province [114]
0
0
Porto
Query!
Country [115]
0
0
Portugal
Query!
State/province [115]
0
0
Vila Nova de Gaia
Query!
Country [116]
0
0
Romania
Query!
State/province [116]
0
0
Baia Mare
Query!
Country [117]
0
0
Romania
Query!
State/province [117]
0
0
Bucharest
Query!
Country [118]
0
0
Romania
Query!
State/province [118]
0
0
Cluj-Napoca
Query!
Country [119]
0
0
Russian Federation
Query!
State/province [119]
0
0
Chelyabinsk
Query!
Country [120]
0
0
Russian Federation
Query!
State/province [120]
0
0
Ekaterinburg
Query!
Country [121]
0
0
Russian Federation
Query!
State/province [121]
0
0
Kemerovo
Query!
Country [122]
0
0
Russian Federation
Query!
State/province [122]
0
0
Moscow
Query!
Country [123]
0
0
Russian Federation
Query!
State/province [123]
0
0
Novosibirsk
Query!
Country [124]
0
0
Russian Federation
Query!
State/province [124]
0
0
Rostov on Don
Query!
Country [125]
0
0
Russian Federation
Query!
State/province [125]
0
0
St. Petersburg
Query!
Country [126]
0
0
Russian Federation
Query!
State/province [126]
0
0
St.Petersburg
Query!
Country [127]
0
0
Russian Federation
Query!
State/province [127]
0
0
Ufa
Query!
Country [128]
0
0
Russian Federation
Query!
State/province [128]
0
0
Volgograd
Query!
Country [129]
0
0
Russian Federation
Query!
State/province [129]
0
0
Voronezh
Query!
Country [130]
0
0
Russian Federation
Query!
State/province [130]
0
0
Yaroslavl
Query!
Country [131]
0
0
Saudi Arabia
Query!
State/province [131]
0
0
Riyadh
Query!
Country [132]
0
0
Serbia
Query!
State/province [132]
0
0
Belgrade
Query!
Country [133]
0
0
Serbia
Query!
State/province [133]
0
0
Kragujevac
Query!
Country [134]
0
0
Serbia
Query!
State/province [134]
0
0
Nis
Query!
Country [135]
0
0
Serbia
Query!
State/province [135]
0
0
Sremska Kamenica
Query!
Country [136]
0
0
Serbia
Query!
State/province [136]
0
0
Valjevo
Query!
Country [137]
0
0
Slovakia
Query!
State/province [137]
0
0
Bardejov
Query!
Country [138]
0
0
Slovakia
Query!
State/province [138]
0
0
Levice
Query!
Country [139]
0
0
Slovakia
Query!
State/province [139]
0
0
Martin
Query!
Country [140]
0
0
Slovakia
Query!
State/province [140]
0
0
Nitra
Query!
Country [141]
0
0
Slovakia
Query!
State/province [141]
0
0
Zilina
Query!
Country [142]
0
0
Slovenia
Query!
State/province [142]
0
0
Celje
Query!
Country [143]
0
0
Slovenia
Query!
State/province [143]
0
0
Golnik
Query!
Country [144]
0
0
Slovenia
Query!
State/province [144]
0
0
Maribor
Query!
Country [145]
0
0
Slovenia
Query!
State/province [145]
0
0
Topolsica
Query!
Country [146]
0
0
Thailand
Query!
State/province [146]
0
0
Bangkok
Query!
Country [147]
0
0
Thailand
Query!
State/province [147]
0
0
Pathum Tani
Query!
Country [148]
0
0
Turkey
Query!
State/province [148]
0
0
Ankara
Query!
Country [149]
0
0
Turkey
Query!
State/province [149]
0
0
Bursa
Query!
Country [150]
0
0
Turkey
Query!
State/province [150]
0
0
Diyarbakir
Query!
Country [151]
0
0
Turkey
Query!
State/province [151]
0
0
Gaziantep
Query!
Country [152]
0
0
Turkey
Query!
State/province [152]
0
0
Isparta
Query!
Country [153]
0
0
Turkey
Query!
State/province [153]
0
0
Istanbul
Query!
Country [154]
0
0
Turkey
Query!
State/province [154]
0
0
Izmir
Query!
Country [155]
0
0
Turkey
Query!
State/province [155]
0
0
Karaman
Query!
Country [156]
0
0
Turkey
Query!
State/province [156]
0
0
Kayseri
Query!
Country [157]
0
0
Turkey
Query!
State/province [157]
0
0
Rize
Query!
Country [158]
0
0
Turkey
Query!
State/province [158]
0
0
Yalova
Query!
Country [159]
0
0
United Arab Emirates
Query!
State/province [159]
0
0
Dubai
Query!
Country [160]
0
0
United Kingdom
Query!
State/province [160]
0
0
Barnsley
Query!
Country [161]
0
0
United Kingdom
Query!
State/province [161]
0
0
Basingstoke
Query!
Country [162]
0
0
United Kingdom
Query!
State/province [162]
0
0
Birmingham
Query!
Country [163]
0
0
United Kingdom
Query!
State/province [163]
0
0
Burton on Trent
Query!
Country [164]
0
0
United Kingdom
Query!
State/province [164]
0
0
Durham
Query!
Country [165]
0
0
United Kingdom
Query!
State/province [165]
0
0
London
Query!
Country [166]
0
0
United Kingdom
Query!
State/province [166]
0
0
Manchester
Query!
Country [167]
0
0
United Kingdom
Query!
State/province [167]
0
0
North Shields
Query!
Country [168]
0
0
United Kingdom
Query!
State/province [168]
0
0
Portadown
Query!
Country [169]
0
0
United Kingdom
Query!
State/province [169]
0
0
Salisbury
Query!
Country [170]
0
0
Vietnam
Query!
State/province [170]
0
0
Hanoi
Query!
Country [171]
0
0
Vietnam
Query!
State/province [171]
0
0
Ho Chi Minh city
Query!
Country [172]
0
0
Vietnam
Query!
State/province [172]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02596230
Query!
Trial related presentations / publications
Goldhaber SZ, Ageno W, Casella IB, Chee KH, Schellong S, Singer DE, Voccia I, Tang W, Schulman S. Safety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE study. J Thromb Thrombolysis. 2022 Feb;53(2):399-409. doi: 10.1007/s11239-021-02463-x. Epub 2021 Aug 28. Ageno W, Casella IB, Chee KH, Schellong S, Schulman S, Singer DE, Desch M, Tang W, Voccia I, Zint K, Goldhaber SZ. Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study. J Thromb Thrombolysis. 2021 Apr;51(3):561-570. doi: 10.1007/s11239-020-02239-9. Goldhaber SZ, Ageno W, Casella IB, Chee KH, Schellong S, Singer DE, Desch M, Reilly PA, Donado E, Tang W, Voccia I, Schulman S. Profile of Patients Diagnosed With Acute Venous Thromboembolism in Routine Clinical Practice: The RE-COVERY DVT/PE Study. Am J Med. 2020 Aug;133(8):936-945. doi: 10.1016/j.amjmed.2020.03.036. Epub 2020 Apr 20.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/30/NCT02596230/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/30/NCT02596230/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02596230