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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism

• Study Type: Observational
• Enrollment (Actual): 7797

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1629AHJ
    • Hospital Universitario Austral
  • Caba, Argentina, 1118
    • Hospital Aleman
  • Caba, Argentina, 1181
    • Hospital Italiano
  • Caba, Argentina, 1428
    • ICBA
  • Temperley, Argentina, 1814
    • Clinica Juncal
• Austria
  • Feldkirch, Austria, 6807
    • LKH Feldkirch
  • Graz, Austria, 8036
    • LKH-Univ. Hospital Graz
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
• Belgium
  • Bruxelles, Belgium, 1070
    • ULB Hôpital Erasme
  • Charleroi, Belgium, 6000
    • C.H.U. de Charleroi
  • Lier, Belgium, 2500
    • H.-Hartziekenhuis
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
• Brazil
  • Belo Horizonte, Brazil, 30140-092
    • Hospital Vera Cruz
  • Campinas, Brazil, 13083970
    • Faculdade de Ciências Médicas da Unicamp
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina - FMUSP
• Bulgaria
  • Plovdiv, Bulgaria, 4014
    • UMHAT St. George
  • Sofia, Bulgaria, 1407
    • MHAT 'Tokuda Hospital Sofia', EAD
  • Sofia, Bulgaria, 1309
    • National Heart Hospital, Sofia
  • Stara Zagora, Bulgaria, 6004
    • Hospital Trakia Park
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Hospital - Hamilton Health Sciences
• Chile
  • Santiago, Chile, 7500922
    • SMOLAM
• Colombia
  • Armenia, Colombia
    • Fundacion Cardiomet Cequin
  • Cali, Colombia, 760036
    • Centro de Investigaciones Clinicas S.A.S
  • Cali, Colombia, 760032
    • Unidad de Investigaciones Clínicas
  • Cartagena, Colombia, 13001
    • Centro de Diagnostico Cardilogico
  • Manizales, Colombia, 170004
    • Asociacion IPS Medicos Internistas de Caldas
  • Medellin, Colombia
    • Promotora Medica Las Americas SA
• Czechia
  • Beroun, Czechia, 266 01
    • Rehabilitacni nemocnice Beroun
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Brno, Czechia, 63900
    • Nemocnice Milosrdnych bratri
  • Brno, Czechia, 639 00
    • University Hospital Brno
  • Brno, Czechia, 61200
    • Diagangio s.r.o.
  • Hodonin, Czechia, 695 01
    • CTC Hodonin s.r.o.
  • Louny, Czechia, 440 01
    • MUDr. Ladislav Busak
  • Mlada Boleslav, Czechia, 293 01
    • MUDr. Stanislav Bulir
  • Nachod, Czechia, 547 69
    • Nemocnice Náchod
  • Olomouc, Czechia, 779 00
    • MUDr. Dalibor Musil
  • Plzen, Czechia, 305 99
    • Fakultni nemocnice Plzen
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Praha 4, Czechia, 140 21
    • Institute for Clinical and Experimental Medicine
• Egypt
  • Alexandria, Egypt, 21131
    • Dr. Ashraf ElGhandour Private Clinic
  • Cairo, Egypt, 11322
    • Private Clinic Dr. Mervat Mattar
  • Cairo, Egypt, 11341
    • Private Clinic Mohamed Moussa
  • Cairo, Egypt, 12345
    • Private Clinic - Dr. Shawky
  • Kalyoub, Egypt, 13632
    • Private Clinic - Dr. Ahmed Hassouna
• Germany
  • Berlin, Germany, 10787
    • Franziskus-Krankenhaus, Berlin
  • Dresden, Germany, 01067
    • Städtisches Klinikum Dresden
  • Goerlitz, Germany, 02827
    • Praxis für Gefäßmedizin
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
• Greece
  • Alexandroupolis, Greece, 68100
    • University Hospital of Alexandroupolis
  • Athens, Greece, 124 62
    • University General Hospital Attikon
  • Athens, Greece, 11527
    • Athens Hospital of Chest Diseases "Sotiria"
  • Athens, Greece, 11527
    • "Laiko" Hospital, 1st Vascular Surgery Clinic of UOA
  • Athens, Greece, 11527
    • Gen. Hosp. of Chest Diseases "Sotiria", 3rd Internal Med. Cl
  • Ioannina, Greece, 45 500
    • Univ. Gen. Hosp. of Ioannina
  • Larissa, Greece, 41110
    • General University Hospital Of Larissa
  • Thessaloniki, Greece, 54636
    • University General Hospital of Thessaloniki AHEPA
  • Thessaloniki, Greece, 54635
    • General Hospital of Athens "G. Gennimatas"
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-Pest Hospital
  • Budapest, Hungary, 1096
    • St. Istvan Hospital, Budapest
  • Debrecen, Hungary, 4032
    • University Debrecen Hospital
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Hospital
  • Nagykanizsa, Hungary, 8800
    • Dorottya Kanizsai Hospital
  • Pecs, Hungary, 7624
    • Pécsi Tudományegyetem
  • Szentes, Hungary, 6600
    • Csongrad Country Dr Bugyi Istvan Hosp.
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
• Italy
  • Acerra, Italy, 80011
    • Clinica Villa dei Fiori
  • Alba, Italy, 15100
    • Ospedale San Lazzaro
  • Bari, Italy, 70100
    • Policlinico di Bari
  • Castelfranco Veneto, Italy, 31033
    • P.O. di Castelfranco Veneto
  • Faenza (RA), Italy, 48022
    • Ospedale Civile degli Infermi
  • Lecce, Italy, 73100
    • Azienda Ospedaliera Vito Fazzi
  • Livorno, Italy, 57124
    • Spedali Riuniti di Livorno
  • Macerata, Italy, 62100
    • Ospedali Riuniti di Ancona
  • Napoli, Italy, 80138
    • SUN Seconda Università Napoli
  • Ortona (CH), Italy, 66026
    • Ospedale Gaetano Bernabeo
  • Palermo, Italy, 90135
    • Osp. Civico e Benfratelli "M. Ascoli e G. Di Cristina"
  • Roma, Italy, 00161
    • Azienda Universitaria-Universita' La Sapienza
  • Roma, Italy, 00168
    • Univ. Cattolica del Sacro Cuore
  • Sassari, Italy, 07100
    • Ospedale Civile
  • Varese, Italy, 21100
    • A. O. Ospedale Circolo Fond. Macchi
  • Vimercate (Mi), Italy, 20059
    • A. O. Ospedale di Vimercate
• Korea, Republic of
  • Anyang-si, Korea, Republic of, 14068
    • Hallym University Sacred Heart Hospital
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of, 41931
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Seoul, Korea, Republic of, 04401
    • Soonchunhyang University Hospital Seoul
• Latvia
  • Daugavpils, Latvia, 5420
    • Daugavpils Regional Hospital
  • Liepaja, Latvia, 3414
    • Liepaja Regional Hospital, Therapy Department
  • Riga, Latvia, 1038
    • Riga East University Hospital
  • Talsi, Latvia, 3201
    • VSV Centrs, Stalte Private Practice, Talsi
  • Ventspils, Latvia, 3601
    • Gita Rancane Doctor Practice in Cardiology
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Beirut, Lebanon
    • Bellevue Medical Center
  • Beirut, Lebanon, 5244
    • Rafik Hariri University Hospital
  • Beirut, Lebanon, 11-2555
    • Clemenceau Medical Center
  • El-Chouf, Lebanon
    • Ain Wazein Hospital
  • Jbeil, Lebanon
    • Centre Hospitalier universitaire Notre Dame de secours
  • Saida, Lebanon, 652
    • Hammoud Hospital University Medical Center
• Malaysia
  • Kota Bahru, Malaysia, 15586
    • Hospital Raja Perempuan Zainab II, Kota Bharu
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• Mexico
  • Guadalajara, Mexico, 44670
    • Clinica Vascular de Guadalajara
  • Guadalajara, Mexico, 44670
    • Instituto Jalisciense de Metabolismo, SC
  • San Luis Potosí, Mexico, 78200
    • Hospital_Angeles Centro Médicodel Potosí
  • Veracruz, Mexico, 91910
    • Arke Estudios Clinicos Sa De Cv
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • OLVG, locatie Oosterpark
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis, locatie Nieuwegein
  • Tilburg, Netherlands, 5042 AD
    • Tweesteden Ziekenhuis, locatie Tilburg
• New Zealand
  • Palmerston North, New Zealand, 4442
    • Palmerston North Hospital
• Peru
  • Piura, Peru, 51
    • Centro Medico Piura
• Philippines
  • Makati, Philippines, 1229
    • Makati Medical Center
  • Manila, Philippines, Philippines, 1000
    • Philippine General Hospital
  • Quezon City, Philippines, 1400
    • St. Luke's Medical Center, QC
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Bytom, Poland, 41-902
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 4
  • Ostroleka, Poland, 07-410
    • Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
  • Wroclaw, Poland, 50-981
    • 4. Military Clinical Hospital with Polyclinic SP ZOZ
• Portugal
  • Ponta Delgada, Portugal, 9500-370
    • Hospital Ponta Delgada
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  • Vila Nova de Gaia, Portugal, 4400-129
    • Centro Hospitalar de Vila Nova de Gaia
• Romania
  • Baia Mare, Romania, 430123
    • Private Practice Cardiology Dr. Pop Calin Florin
  • Bucharest, Romania, 050098
    • Emergency University Hospital, Bucharest
  • Cluj-Napoca, Romania, 400136
    • Spitalul Clinic Municipal Cluj Napoca
• Russian Federation
  • Chelyabinsk, Russian Federation, 454021
    • Regional Clinical Hospital#3
  • Ekaterinburg, Russian Federation, 620063
    • Medical Center "Angioline"
  • Ekaterinburg, Russian Federation, 620109
    • LLC Medical Union New Hospital
  • Kemerovo, Russian Federation, 650066
    • State Autonomous Institution of Health
  • Moscow, Russian Federation, 111539
    • Hospital #15 named after O.M.Filatov
  • Moscow, Russian Federation, 115682
    • Federal Research and Clinical Center of Special Medical Help
  • Moscow, Russian Federation, 117049
    • City Clinical Hospital 1 (1-Gradskaya)
  • Moscow, Russian Federation, 127644
    • City Clinical Hospital n.a. V.V. Veresaev
  • Novosibirsk, Russian Federation, 630055
    • Novosibirsk Research Institute
  • Rostov on Don, Russian Federation, 344022
    • Rostov Medical University
  • St. Petersburg, Russian Federation, 195257
    • City Hospital Saint Elizaveta, Dept. Endocrinology
  • St. Petersburg, Russian Federation, 194354
    • City Clinical Hospital No. 2, St. Petersburg
  • St.Petersburg, Russian Federation, 195067
    • St.Petersburg State Medical University n. a. II Mechnikov
  • St.Petersburg, Russian Federation, 195271
    • Dorozghnaya hospital
  • Ufa, Russian Federation, 450081
    • Clinical hospital of BGMU
  • Volgograd, Russian Federation, 400026
    • Clinical emergency hospital #15
  • Voronezh, Russian Federation, 394066
    • Voronezh Regional Hospital N1
  • Yaroslavl, Russian Federation, 150062
    • Yaroslavl Regional Clin. Hospital
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11525
    • King Fahad Medical City
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Medical Center Zvezdara, Belgrade
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska kosa, Belgrade
  • Belgrade, Serbia, 11000
    • Institute for Cardiovascular diseases Dedinje
  • Belgrade, Serbia, 11070
    • General Hospital MediGroup
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Clinical Centre Nis
  • Sremska Kamenica, Serbia, 21204
    • Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
  • Valjevo, Serbia, 14000
    • General Hospital Valjevo
• Slovakia
  • Bardejov, Slovakia, 08501
    • ALIAN s.r.o., Bardejov, Dzupinova, Maria
  • Levice, Slovakia, 934 01
    • KARDIO-ANGIO, s.r.o.
  • Martin, Slovakia, 036 01
    • HeMart, s.r.o.
  • Nitra, Slovakia, 949 01
    • ABE-AS, s.r.o.
  • Zilina, Slovakia, 010 01
    • MEDIVASA s.r.o., Outpatient Clinic, Zilina
• Slovenia
  • Celje, Slovenia, 3000
    • GH Celje
  • Golnik, Slovenia, 4204
    • Univ. Clinic of Respiratory and Allergic Diseases, Golnik
  • Maribor, Slovenia, 2000
    • UCC Maribor
  • Topolsica, Slovenia, 3326
    • Hospital Topolšica
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Pathum Tani, Thailand, 12120
    • Thammasat University Hospital
• Turkey
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty
  • Ankara, Turkey, 06800
    • Ankara Ataturk Training and Research Hospital
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty
  • Diyarbakir, Turkey, 21830
    • Dicle University Medical Faculty
  • Gaziantep, Turkey, 27010
    • Dr. Ersin Arslan Public Hospital
  • Isparta, Turkey, 32260
    • Suleyman Demirel University Medical Faculty
  • Istanbul, Turkey, 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey, 34147
    • Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Zuhura
  • Izmir, Turkey
    • Ege University Medical Faculty
  • Izmir, Turkey, 35520
    • Izmir Tepecik Training and Research Hospital
  • Karaman, Turkey
    • Karaman Government Hospital
  • Kayseri, Turkey, 38010
    • Kayseri Training and Research Hospital
  • Rize, Turkey, 53200
    • RTE University Medical Faculty
  • Yalova, Turkey, 77200
    • Ozel Uzmanlar Yalova Hospital
• United Arab Emirates
  • Dubai, United Arab Emirates, 41840
    • Thumbay Hospital
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley Hospital
  • Basingstoke, United Kingdom, RG24 9NA
    • North Hampshire Hospital
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Burton on Trent, United Kingdom, DE13 0RB
    • Queen's Hospital
  • Durham, United Kingdom, DH1 5TW
    • University Hospital of North Durham
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • North Shields, United Kingdom, NE29 8NH
    • North Tyneside General Hospital
  • Portadown, United Kingdom, BT63 5QQ
    • Craigavon Area Hospital
  • Salisbury, United Kingdom, SP2 8BJ
    • Salisbury District Hospital
• United States
  • California
    • Long Beach, California, United States, 90813
      • Cardiovascular Innovation and Research Center
  • Florida
    • Miami, Florida, United States, 33165
      • Med-Care Research
    • Miami, Florida, United States, 33155
      • Health and Life Research Institute, LLC
    • Pembroke Pines, Florida, United States, 33026
      • Pines Care Research Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Ellipsis Group
    • Marietta, Georgia, United States, 30060
      • Wellstar Cardiovascular Medicine
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Fox Valley Clinical Research Center, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • North Carolina
    • Kinston, North Carolina, United States, 28501
      • Vidant Multispecialty Clnc Kinston
    • Sanford, North Carolina, United States, 27330
      • Sanford Cardiology
  • Pennsylvania
    • Jersey Shore, Pennsylvania, United States, 17740
      • Lycoming Internal Medicine, Inc
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Research Associates Of Jackson
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas at Houston
    • Katy, Texas, United States, 77450
      • Cardiology Center of Houston, PA
    • McKinney, Texas, United States, 75071
      • Cardio Voyage
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Heart Institute
• Vietnam
  • Hanoi, Vietnam, 100000
    • Bach Mai hospital
  • Ho Chi Minh, Vietnam, 700000
    • 115 People Hospital
  • Ho Chi Minh, Vietnam, 700000
    • Gia Dinh People Hospital
  • Ho Chi Minh, Vietnam, 70000
    • Cho Ray Hospital
  • Ho Chi Minh city, Vietnam, 70000
    • University Medical Center of Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute venous thromboembolism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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.	12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2015
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 1160.188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED