Clinical trial NCT02596230: RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
Official title: Characterization of Patients Following Acute Venous Thromboembolism (VTE) and Safety and Effectiveness of Dabigatran Etexilate (DE) in the Treatment and Secondary Prevention of Acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Comparison to Vitamin K Antagonist (VKA) in Routine Clinical Practice - RE-COVERY DVT/PE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 7797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute venous thromboembolism

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.


Eligibility criteria: Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations
2. Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)
3. Age \>= 18 years
4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months
5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection

Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism (VTE)
2. Current participation in a clinical trial for VTE indication or current use of an unapproved drug

Primary outcomes:
measure: Objective 1: Age
timeFrame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 1: Sex
timeFrame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 1: Index Event
timeFrame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 1: Anticoagulant Treatment
timeFrame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: 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)
timeFrame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
timeFrame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary outcomes:
measure: Objective 2: Incidence Rate of Recurrent DVT and/or PE
timeFrame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 2: Incidence Rate of VTE-related Mortality
timeFrame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
measure: Objective 2: Incidence Rate of All-cause Mortality
timeFrame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Cardiovascular Innovation and Research Center
state: California
city: Miami
country: United States
facility: Health and Life Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Ellipsis Group
state: Georgia
city: Marietta
country: United States
facility: Wellstar Cardiovascular Medicine
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Jackson
country: United States
facility: University Of Mississippi Medical Center
state: Mississippi
city: Kinston
country: United States
facility: Vidant Multispecialty Clnc Kinston
state: North Carolina
city: Sanford
country: United States
facility: Sanford Cardiology
state: North Carolina
city: Jersey Shore
country: United States
facility: Lycoming Internal Medicine, Inc
state: Pennsylvania
city: Jackson
country: United States
facility: Research Associates of Jackson
state: Tennessee
city: Houston
country: United States
facility: The University Of Texas at Houston
state: Texas
city: Katy
country: United States
facility: Cardiology Center of Houston, PA
state: Texas
city: McKinney
country: United States
facility: Cardio Voyage
state: Texas
city: Waukesha
country: United States
facility: Waukesha Heart Institute
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
city: Caba
country: Argentina
facility: Hospital Aleman
city: Caba
country: Argentina
facility: Hospital Italiano
city: Caba
country: Argentina
facility: ICBA
city: Temperley
country: Argentina
facility: Clinica Juncal
city: Feldkirch
country: Austria
facility: LKH Feldkirch
city: Graz
country: Austria
facility: LKH-Univ. Hospital Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Charleroi
country: Belgium
facility: C.H.U. de Charleroi
city: Lier
country: Belgium
facility: H.-Hartziekenhuis
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz
city: Campinas
country: Brazil
facility: Faculdade de Ciencias Medicas da UNICAMP
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina - FMUSP
city: Plovdiv
country: Bulgaria
facility: UMHAT St. George
city: Sofia
country: Bulgaria
facility: National Heart Hospital, Sofia
city: Sofia
country: Bulgaria
facility: MHAT 'Tokuda Hospital Sofia', EAD
city: Stara Zagora
country: Bulgaria
facility: Hospital Trakia Park
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital - Hamilton Health Sciences
state: Ontario
city: Santiago
country: Chile
facility: SMOLAM
city: Armenia
country: Colombia
facility: Fundacion Cardiomet CEQUIN
city: Cali
country: Colombia
facility: Unidad de Investigaciones Clínicas
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S.A.S
city: Cartagena
country: Colombia
facility: Centro de Diagnostico Cardilogico
city: Manizales
country: Colombia
facility: Asociacion IPS Medicos Internistas de Caldas
city: Medellin
country: Colombia
facility: Promotora Medica Las Americas SA
city: Beroun
country: Czechia
facility: Rehabilitacni nemocnice Beroun
city: Brno
country: Czechia
facility: Diagangio s.r.o.
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: Nemocnice Milosrdnych bratri
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hodonin
country: Czechia
facility: CTC Hodonin s.r.o.
city: Louny
country: Czechia
facility: MUDr. Ladislav Busak
city: Mlada Boleslav
country: Czechia
facility: MUDr. Stanislav Bulir
city: Nachod
country: Czechia
facility: Nemocnice Náchod
city: Olomouc
country: Czechia
facility: MUDr. Dalibor Musil
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice V Praze
city: Praha 4
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Alexandria
country: Egypt
facility: Dr. Ashraf ElGhandour Private Clinic
city: Cairo
country: Egypt
facility: Private Clinic Dr. Mervat Mattar
city: Cairo
country: Egypt
facility: Private Clinic Mohamed Moussa
city: Cairo
country: Egypt
facility: Private Clinic - Dr. Shawky
city: Kalyoub
country: Egypt
facility: Private Clinic - Dr. Ahmed Hassouna
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus, Berlin
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Goerlitz
country: Germany
facility: Praxis für Gefäßmedizin
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: "Laiko" Hospital, 1st Vascular Surgery Clinic of UOA
city: Athens
country: Greece
facility: Athens Hospital of Chest Diseases "Sotiria"
city: Athens
country: Greece
facility: Gen. Hosp. of Chest Diseases "Sotiria", 3rd Internal Med. Cl
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat
city: Budapest
country: Hungary
facility: St. Istvan Hospital, Budapest
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-Pest Hospital
city: Debrecen
country: Hungary
facility: University Debrecen Hospital
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Hospital
city: Nagykanizsa
country: Hungary
facility: Dorottya Kanizsai Hospital
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szentes
country: Hungary
facility: Csongrad Country Dr Bugyi Istvan Hosp.
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
city: Acerra
country: Italy
facility: Clinica Villa dei Fiori
city: Alba
country: Italy
facility: Ospedale san Lazzaro
city: Bari
country: Italy
facility: Policlinico di Bari
city: Castelfranco Veneto
country: Italy
facility: P.O. di Castelfranco Veneto
city: Faenza (RA)
country: Italy
facility: Ospedale Civile degli Infermi
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
city: Livorno
country: Italy
facility: Spedali Riuniti di Livorno
city: Macerata
country: Italy
facility: Ospedali Riuniti di Ancona
city: Napoli
country: Italy
facility: SUN Seconda Università Napoli
city: Ortona (CH)
country: Italy
facility: Ospedale Gaetano Bernabeo
city: Palermo
country: Italy
facility: Osp. Civico e Benfratelli "M. Ascoli e G. Di Cristina"
city: Roma
country: Italy
facility: Azienda Universitaria-Universita' La Sapienza
city: Roma
country: Italy
facility: Univ. Cattolica del Sacro Cuore
city: Sassari
country: Italy
facility: Ospedale Civile
city: Varese
country: Italy
facility: A. O. Ospedale Circolo Fond. Macchi
city: Vimercate (Mi)
country: Italy
facility: A. O. Ospedale di Vimercate
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital, Therapy Department
city: Riga
country: Latvia
facility: Riga East University Hospital
city: Talsi
country: Latvia
facility: VSV Centrs, Stalte Private Practice, Talsi
city: Ventspils
country: Latvia
facility: Gita Rancane Doctor Practice in Cardiology
city: Beirut
country: Lebanon
facility: Clemenceau Medical Center
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Bellevue Medical Center
city: El-Chouf
country: Lebanon
facility: Ain Wazein Hospital
city: Jbeil
country: Lebanon
facility: Centre Hospitalier Universitaire Notre Dame de Secours
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Kota Bahru
country: Malaysia
facility: Hospital Raja Perempuan Zainab II, Kota Bharu
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Guadalajara
country: Mexico
facility: Clinica Vascular de Guadalajara
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Metabolismo, SC
city: San Luis Potosí
country: Mexico
facility: Hospital_Angeles Centro Médicodel Potosí
city: Veracruz
country: Mexico
facility: Arke Estudios Clinicos SA de CV
city: Amsterdam
country: Netherlands
facility: OLVG, locatie Oosterpark
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Tilburg
country: Netherlands
facility: Tweesteden Ziekenhuis, locatie Tilburg
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Piura
country: Peru
facility: Centro Medico Piura
city: Makati
country: Philippines
facility: Makati Medical Center
city: Manila, Philippines
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center, QC
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Bytom
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 4
city: Ostroleka
country: Poland
facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
city: Wroclaw
country: Poland
facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ
city: Ponta Delgada
country: Portugal
facility: Hospital Ponta Delgada
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Baia Mare
country: Romania
facility: Private Practice Cardiology Dr. Pop Calin Florin
city: Bucharest
country: Romania
facility: Emergency University Hospital, Bucharest
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Municipal Cluj Napoca
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Hospital#3
city: Ekaterinburg
country: Russian Federation
facility: Medical Center "Angioline"
city: Ekaterinburg
country: Russian Federation
facility: LLC Medical Union New Hospital
city: Kemerovo
country: Russian Federation
facility: State Autonomous Institution of Health
city: Moscow
country: Russian Federation
facility: Hospital #15 named after O.M.Filatov
city: Moscow
country: Russian Federation
facility: Federal Research and Clinical Center of Special Medical Help
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 1 (1-Gradskaya)
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. V.V. Veresaev
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute
city: Rostov on Don
country: Russian Federation
facility: Rostov Medical University
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital No. 2, St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: City Hospital Saint Elizaveta, Dept. Endocrinology
city: St.Petersburg
country: Russian Federation
facility: St.Petersburg State Medical University n. a. II Mechnikov
city: St.Petersburg
country: Russian Federation
facility: Dorozghnaya hospital
city: Ufa
country: Russian Federation
facility: Clinical hospital of BGMU
city: Volgograd
country: Russian Federation
facility: Clinical emergency hospital #15
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Hospital N1
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clin. Hospital
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Medical Center Zvezdara, Belgrade
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular diseases Dedinje
city: Belgrade
country: Serbia
facility: General Hospital MediGroup
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska kosa, Belgrade
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Centre Nis
city: Sremska Kamenica
country: Serbia
facility: Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
city: Valjevo
country: Serbia
facility: General Hospital Valjevo
city: Bardejov
country: Slovakia
facility: ALIAN s.r.o., Bardejov, Dzupinova, Maria
city: Levice
country: Slovakia
facility: KARDIO-ANGIO, s.r.o.
city: Martin
country: Slovakia
facility: HeMart, s.r.o.
city: Nitra
country: Slovakia
facility: ABE-AS, s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA s.r.o., Outpatient Clinic, Zilina
city: Celje
country: Slovenia
facility: GH Celje
city: Golnik
country: Slovenia
facility: Univ. Clinic of Respiratory and Allergic Diseases, Golnik
city: Maribor
country: Slovenia
facility: UCC Maribor
city: Topolsica
country: Slovenia
facility: Hospital Topolsica
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Pathum Tani
country: Thailand
facility: Thammasat University Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Atatürk Training and Research Hospital
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Public Hospital
city: Isparta
country: Turkey
facility: Suleyman Demirel University Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Zuhura
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Karaman
country: Turkey
facility: Karaman Government Hospital
city: Kayseri
country: Turkey
facility: Kayseri Training And Research Hospital
city: Rize
country: Turkey
facility: RTE University Medical Faculty
city: Yalova
country: Turkey
facility: Ozel Uzmanlar Yalova Hospital
city: Dubai
country: United Arab Emirates
facility: Thumbay Hospital
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Burton on Trent
country: United Kingdom
facility: Queen's Hospital
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Portadown
country: United Kingdom
facility: Craigavon Area Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai hospital
city: Ho Chi Minh city
country: Vietnam
facility: University Medical Center of Ho Chi Minh City
city: Ho Chi Minh
country: Vietnam
facility: 115 People Hospital
city: Ho Chi Minh
country: Vietnam
facility: Gia Dinh People Hospital
city: Ho Chi Minh
country: Vietnam
facility: Cho Ray Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.