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CompletedNCT02596230Updated Apr 29, 2020Results posted

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

An observational study in Venous Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 222 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,797
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Venous Thromboembolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 7,797 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute venous thromboembolism

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,797 participants (actual)
Patient registry
No

Groups and 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

06

What researchers measure

Primary outcomes

  1. Objective 1: Age

    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.

    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).

  2. Objective 1: Sex

    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.

    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).

  3. Objective 1: Index Event

    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.

    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).

  4. Objective 1: Anticoagulant Treatment

    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.

    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).

  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)

    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.

    Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

  6. Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality

    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.

    Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Secondary outcomes

  1. Objective 2: Incidence Rate of Recurrent DVT and/or 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.

    Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

  2. Objective 2: Incidence Rate of VTE-related Mortality

    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.

    Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

  3. Objective 2: Incidence Rate of All-cause Mortality

    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.

    Time frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

07

Results

Posted Apr 29, 2020

Participant flow

This study characterizes patients following acute venous thromboembolism and assesses the safety and effectiveness of dabigatran etexilate in the treatment and secondary prevention of acute DVT and PE in comparison to vitamin K antagonist in routine clinical practice. This is a large multi-center observational study based on new data collection.

Objective 1, One Visit During 14 Days
Participant flow — Objective 1, One Visit During 14 Days
MilestoneNot Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)
Started37141006013750
Completed37141006013750
Not completed00000
Screening Period for Objective 2
Participant flow — Screening Period for Objective 2
MilestoneNot Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)
Started371410069101375792
Completed0778910529792
Not completed371422808460
Withdrew: Participants not participating in obj 2371422808460
Objective 2, One Year
Participant flow — Objective 2, One Year
MilestoneNot Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)
Started0778910529792
Completed0710812471714
Not completed068985878
Withdrew: Lost to follow-up041413246
Withdrew: Withdrawal by subject0111452
Withdrew: Adverse drug reaction01000
Withdrew: Death012412130
Withdrew: Other03200

Outcome measures

PrimaryObjective 1: Age

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.

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).
Reported as:
Mean · years
Objective 1: Age
yearsAll Participants With a DVT and/or PE
Objective 1: Age61.5 ± 17.0
PrimaryObjective 1: Sex

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.

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).
Reported as:
Count of participants · Participants
Objective 1: Sex
ParticipantsAll Participants With a DVT and/or PE
Male — Participants3062
Female — Participants3032
Missing data — Participants1
PrimaryObjective 1: Index Event

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.

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).
Reported as:
Count of participants · Participants
Objective 1: Index Event
ParticipantsAll Participants With a DVT and/or PE
DVT — Participants3644
PE — Participants1588
DVT and PE — Participants863
PrimaryObjective 1: Anticoagulant Treatment

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.

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).
Reported as:
Count of participants · Participants
Objective 1: Anticoagulant Treatment
ParticipantsAll Participants With a DVT and/or PE
Dabigatran — Participants947
vitamin K antagonist (VKA) — Participants1388
Edoxaban — Participants103
Rivaroxaban — Participants1558
Apixaban — Participants686
Other — Participants1413
PrimaryObjective 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)

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.

Time frame:
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Reported as:
Number · events per 100 patient-years
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)
events per 100 patient-yearsDabigatran EtexilateVitamin K Antagonist
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)2.63 (1.79 to 3.73)4.42 (3.18 to 5.97)
Statistical analysis
  • Dabigatran Etexilate vs Vitamin K Antagonist · Regression, Cox · p = 0.188 (One-side p-value) · Hazard ratio (hr): 0.634 · 95% CI 0.322 to 1.249Hazard Ratio \< 1 favors Dabigatran etexilate.
PrimaryObjective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality

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.

Time frame:
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Reported as:
Number · events per 100 patient-years
Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
events per 100 patient-yearsDabigatran EtexilateVitamin K Antagonist
Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality1.53 (0.91 to 2.42)2.01 (1.21 to 3.14)
Statistical analysis
  • Dabigatran Etexilate vs Vitamin K Antagonist · Regression, Cox · p = 0.606 (One-side p-value) · Hazard ratio (hr): 0.778 · 95% CI 0.300 to 2.017Hazard Ratio \< 1 favors Dabigatran etexilate.
SecondaryObjective 2: Incidence Rate of Recurrent DVT and/or 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.

Time frame:
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Reported as:
Number · events per 100 patient-years
Objective 2: Incidence Rate of Recurrent DVT and/or PE
events per 100 patient-yearsDabigatran EtexilateVitamin K Antagonist
Objective 2: Incidence Rate of Recurrent DVT and/or PE1.61 (0.97 to 2.52)2.22 (1.38 to 3.40)
Statistical analysis
  • Dabigatran Etexilate vs Vitamin K Antagonist · Regression, Cox · p = 0.542 (One-side p-value) · Hazard ratio (hr): 0.751 · 95% CI 0.299 to 1.885Hazard Ratio \< 1 favors Dabigatran etexilate.
SecondaryObjective 2: Incidence Rate of VTE-related Mortality

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.

Time frame:
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Reported as:
Number · events per 100 patient-years
Objective 2: Incidence Rate of VTE-related Mortality
events per 100 patient-yearsDabigatran EtexilateVitamin K Antagonist
Objective 2: Incidence Rate of VTE-related Mortality0 (0 to 0)0.42 (0.11 to 1.08)
Statistical analysis
  • Dabigatran Etexilate vs Vitamin K Antagonist · Regression, Cox · p = 0.996 (One-side p-value) · Hazard ratio (hr): 0.00Hazard Ratio \< 1 favors Dabigatran etexilate. Hazard Ratio is actually \<0.01 95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events.
SecondaryObjective 2: Incidence Rate of All-cause Mortality

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.

Time frame:
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Reported as:
Number · events per 100 patient-years
Objective 2: Incidence Rate of All-cause Mortality
events per 100 patient-yearsDabigatran EtexilateVitamin K Antagonist
Objective 2: Incidence Rate of All-cause Mortality2.12 (1.37 to 3.12)3.06 (2.05 to 4.39)
Statistical analysis
  • Dabigatran Etexilate vs Vitamin K Antagonist · Regression, Cox · p = 0.690 (One-side p-value) · Hazard ratio (hr): 0.857 · 95% CI 0.402 to 1.828Hazard Ratio \< 1 favors Dabigatran etexilate.

Adverse events

Collected over From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist54/3,714 (1.5%)60/3,714 (1.6%)0/3,714 (0%)
Dabigatran Etexilate (1)13/1,006 (1.3%)22/1,006 (2.2%)0/1,006 (0%)
Dabigatran Etexilate (2)42/910 (4.6%)47/910 (5.2%)0/910 (0%)
Vitamin K Antagonist (1)25/1,375 (1.8%)34/1,375 (2.5%)0/1,375 (0%)
Vitamin K Antagonist (2)30/792 (3.8%)41/792 (5.2%)0/792 (0%)
Most frequent serious events
Showing 10 of 107
Most frequent serious events
EventNot Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)
DeathGeneral disorders7/37143/10066/9107/13757/792
Cardiac arrestCardiac disorders5/37140/10065/9100/13751/792
Cardio-respiratory arrestCardiac disorders1/37141/10064/9102/13750/792
Respiratory failureRespiratory, thoracic and mediastinal disorders0/37140/10063/9101/13752/792
Upper gastrointestinal haemorrhageGastrointestinal disorders3/37140/10060/9100/13752/792
PneumoniaInfections and infestations2/37141/10060/9100/13752/792
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/37141/10062/9101/13752/792
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/37140/10060/9100/13752/792
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/37140/10060/9103/13751/792
HaematuriaRenal and urinary disorders0/37142/10061/9101/13750/792

Baseline characteristics

All Eligible: patients fulfilling all inclusion criteria and no exclusion criteria.

Age, Continuous
Age, Continuous(Years)Not Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)Total
Mean62.5 ± 17.258.3 ± 16.658.4 ± 16.661.3 ± 16.659.0 ± 16.660.9 ± 17.0
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Not Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)Total
Male18065484777084173956
Female19074584336673753840
Missing100001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Not Assigned to Dabigatran Etexilate or Vitamin K AntagonistDabigatran Etexilate (1)Dabigatran Etexilate (2)Vitamin K Antagonist (1)Vitamin K Antagonist (2)Total
American Indian or Alaska Native2122714
Asian42014914796124936
Native Hawaiian or Other Pacific Islander400004
Black or African American111277118209
White262082874211526005942
More than one race561174271
Unknown or Not Reported552201471621
08

Study locations

222 sites
  • Cardiovascular Innovation and Research Center
    Long Beach, California 90813, United States
  • Health and Life Research Institute, LLC
    Miami, Florida 33155, United States
  • Med-Care Research
    Miami, Florida 33165, United States
  • Pines Care Research Center
    Pembroke Pines, Florida 33026, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Ellipsis Group
    Atlanta, Georgia 30342, United States
  • Wellstar Cardiovascular Medicine
    Marietta, Georgia 30060, United States
  • Fox Valley Clinical Research Center, LLC
    Aurora, Illinois 60504, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Genesys Regional Medical Center
    Grand Blanc, Michigan 48439, United States
  • University Of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Vidant Multispecialty Clnc Kinston
    Kinston, North Carolina 28501, United States
  • Sanford Cardiology
    Sanford, North Carolina 27330, United States
  • Lycoming Internal Medicine, Inc
    Jersey Shore, Pennsylvania 17740, United States
  • Research Associates of Jackson
    Jackson, Tennessee 38301, United States
  • The University Of Texas at Houston
    Houston, Texas 77030, United States
  • Cardiology Center of Houston, PA
    Katy, Texas 77450, United States
  • Cardio Voyage
    McKinney, Texas 75071, United States
  • Waukesha Heart Institute
    Waukesha, Wisconsin 53188, United States
  • Hospital Universitario Austral
    Buenos Aires, B1629AHJ, Argentina
  • Hospital Aleman
    Caba, 1118, Argentina
  • Hospital Italiano
    Caba, 1181, Argentina
  • ICBA
    Caba, 1428, Argentina
  • Clinica Juncal
    Temperley, 1814, Argentina
  • LKH Feldkirch
    Feldkirch, 6807, Austria
  • LKH-Univ. Hospital Graz
    Graz, 8036, Austria
  • Medical University of Innsbruck
    Innsbruck, 6020, Austria
  • ULB Hopital Erasme
    Bruxelles, 1070, Belgium
  • C.H.U. de Charleroi
    Charleroi, 6000, Belgium
  • H.-Hartziekenhuis
    Lier, 2500, Belgium
  • Centre Hospitalier Universitaire de Liège
    Liège, 4000, Belgium
  • Hospital Vera Cruz
    Belo Horizonte, 30140-092, Brazil
  • Faculdade de Ciencias Medicas da UNICAMP
    Campinas, 13083970, Brazil
  • Hospital das Clinicas da Faculdade de Medicina - FMUSP
    São Paulo, 05403-000, Brazil
  • UMHAT St. George
    Plovdiv, 4014, Bulgaria
  • National Heart Hospital, Sofia
    Sofia, 1309, Bulgaria
  • MHAT 'Tokuda Hospital Sofia', EAD
    Sofia, 1407, Bulgaria
  • Hospital Trakia Park
    Stara Zagora, 6004, Bulgaria
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
  • Juravinski Hospital - Hamilton Health Sciences
    Hamilton, Ontario L8V 1C3, Canada
  • SMOLAM
    Santiago, 7500922, Chile
  • Fundacion Cardiomet CEQUIN
    Armenia, Colombia
  • Unidad de Investigaciones Clínicas
    Cali, 760032, Colombia
  • Centro de Investigaciones Clinicas S.A.S
    Cali, 760036, Colombia
  • Centro de Diagnostico Cardilogico
    Cartagena, 13001, Colombia
  • Asociacion IPS Medicos Internistas de Caldas
    Manizales, 170004, Colombia
  • Promotora Medica Las Americas SA
    Medellin, Colombia
  • Rehabilitacni nemocnice Beroun
    Beroun, 266 01, Czechia
  • Diagangio s.r.o.
    Brno, 61200, Czechia
  • University Hospital Brno
    Brno, 639 00, Czechia
  • Nemocnice Milosrdnych bratri
    Brno, 63900, Czechia
  • Fakultni nemocnice u sv. Anny v Brne
    Brno, 656 91, Czechia
  • CTC Hodonin s.r.o.
    Hodonin, 695 01, Czechia
  • MUDr. Ladislav Busak
    Louny, 440 01, Czechia
  • MUDr. Stanislav Bulir
    Mlada Boleslav, 293 01, Czechia
  • Nemocnice Náchod
    Nachod, 547 69, Czechia
  • MUDr. Dalibor Musil
    Olomouc, 779 00, Czechia
  • Fakultni nemocnice Plzen
    Plzen, 305 99, Czechia
  • Vseobecna fakultni nemocnice V Praze
    Praha 2, 128 08, Czechia
  • Institute for Clinical and Experimental Medicine
    Praha 4, 140 21, Czechia
  • Dr. Ashraf ElGhandour Private Clinic
    Alexandria, 21131, Egypt
  • Private Clinic Dr. Mervat Mattar
    Cairo, 11322, Egypt
  • Private Clinic Mohamed Moussa
    Cairo, 11341, Egypt
  • Private Clinic - Dr. Shawky
    Cairo, 12345, Egypt
  • Private Clinic - Dr. Ahmed Hassouna
    Kalyoub, 13632, Egypt
  • Franziskus-Krankenhaus, Berlin
    Berlin, 10787, Germany
  • Städtisches Klinikum Dresden
    Dresden, 01067, Germany
  • Praxis für Gefäßmedizin
    Goerlitz, 02827, Germany
  • Universitätsmedizin Greifswald
    Greifswald, 17475, Germany
  • Universitätsklinikum Heidelberg
    Heidelberg, 69120, Germany
  • University Hospital of Alexandroupolis
    Alexandroupolis, 68100, Greece
  • "Laiko" Hospital, 1st Vascular Surgery Clinic of UOA
    Athens, 11527, Greece
  • Athens Hospital of Chest Diseases "Sotiria"
    Athens, 11527, Greece
  • Gen. Hosp. of Chest Diseases "Sotiria", 3rd Internal Med. Cl
    Athens, 11527, Greece
  • University General Hospital Attikon
    Athens, 124 62, Greece
  • Univ. Gen. Hosp. of Ioannina
    Ioannina, 45 500, Greece
  • General University Hospital of Larissa
    Larissa, 41110, Greece
  • General Hospital of Athens "G. Gennimatas"
    Thessaloniki, 54635, Greece
  • University General Hospital of Thessaloniki AHEPA
    Thessaloniki, 54636, Greece
  • Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat
    Balassagyarmat, 2660, Hungary
  • St. Istvan Hospital, Budapest
    Budapest, 1096, Hungary
  • Jahn Ferenc Del-Pest Hospital
    Budapest, 1204, Hungary
  • University Debrecen Hospital
    Debrecen, 4032, Hungary
  • Pest Megyei Flor Ferenc Hospital
    Kistarcsa, 2143, Hungary
  • Dorottya Kanizsai Hospital
    Nagykanizsa, 8800, Hungary
  • Pecsi Tudomanyegyetem
    Pecs, 7624, Hungary
  • Csongrad Country Dr Bugyi Istvan Hosp.
    Szentes, 6600, Hungary
  • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
    Szolnok, 5000, Hungary
  • Clinica Villa dei Fiori
    Acerra, 80011, Italy
  • Ospedale san Lazzaro
    Alba, 15100, Italy
  • Policlinico di Bari
    Bari, 70100, Italy
  • P.O. di Castelfranco Veneto
    Castelfranco Veneto, 31033, Italy
  • Ospedale Civile degli Infermi
    Faenza (RA), 48022, Italy
  • Azienda Ospedaliera Vito Fazzi
    Lecce, 73100, Italy
  • Spedali Riuniti di Livorno
    Livorno, 57124, Italy
  • Ospedali Riuniti di Ancona
    Macerata, 62100, Italy
  • SUN Seconda Università Napoli
    Napoli, 80138, Italy
  • Ospedale Gaetano Bernabeo
    Ortona (CH), 66026, Italy
  • Osp. Civico e Benfratelli "M. Ascoli e G. Di Cristina"
    Palermo, 90135, Italy
  • Azienda Universitaria-Universita' La Sapienza
    Roma, 00161, Italy

Showing the first 100 of 222 sites across 37 countries.

09

References and documents

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. PubMed 34453675 ↗
  • 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. PubMed 32851572 ↗
  • 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. PubMed 32325043 ↗

Study documents

  • Statistical analysis plan · Apr 5, 2017
  • Study protocol · Nov 16, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02596230
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Nov 5, 2015
Primary completion
Mar 31, 2019
Completion
Mar 31, 2019
Results posted
Apr 29, 2020
Last update
Apr 29, 2020

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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