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AzTrials

Venous ThromboembolismNCT02596230

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

An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 222 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
How many people
7,797 participants
Where
222 sitesin 37 countries
Study dates
5 Nov 2015to 31 Mar 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute venous thromboembolism

Who may be able to join

  • Written informed consent provided by the patient in accordance with local regulations
  • 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)
  • Age >= 18 years
  • For Objective 2, the planned anticoagulation therapy should be for at least 3 months
  • For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection

Who cannot join

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

Trial locations and contacts

222 sites in 37 countries.

222 sites in 37 countries

United States19 sites

  • Ellipsis Group

    Atlanta, Georgia, 30342

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60504

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • The University Of Texas at Houston

    Houston, Texas, 77030

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Lycoming Internal Medicine, Inc

    Jersey Shore, Pennsylvania, 17740

  • Cardiology Center of Houston, PA

    Katy, Texas, 77450

  • Vidant Multispecialty Clnc Kinston

    Kinston, North Carolina, 28501

  • Cardiovascular Innovation and Research Center

    Long Beach, California, 90813

  • Wellstar Cardiovascular Medicine

    Marietta, Georgia, 30060

  • Cardio Voyage

    McKinney, Texas, 75071

  • Health and Life Research Institute, LLC

    Miami, Florida, 33155

  • Med-Care Research

    Miami, Florida, 33165

  • Pines Care Research Center

    Pembroke Pines, Florida, 33026

  • Sanford Cardiology

    Sanford, North Carolina, 27330

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Waukesha Heart Institute

    Waukesha, Wisconsin, 53188

Other trials in United States

Russia18 sites

  • Regional Clinical Hospital#3

    Chelyabinsk, 454021

  • State Autonomous Institution of Health

    Kemerovo, 650066

  • Hospital #15 named after O.M.Filatov

    Moscow, 111539

  • Federal Research and Clinical Center of Special Medical Help

    Moscow, 115682

  • City Clinical Hospital 1 (1-Gradskaya)

    Moscow, 117049

  • City Clinical Hospital n.a. V.V. Veresaev

    Moscow, 127644

  • Novosibirsk Research Institute

    Novosibirsk, 630055

  • Rostov Medical University

    Rostov-on-Don, 344022

  • City Clinical Hospital No. 2, St. Petersburg

    Saint Petersburg, 194354

  • St.Petersburg State Medical University n. a. II Mechnikov

    Saint Petersburg, 195067

  • City Hospital Saint Elizaveta, Dept. Endocrinology

    Saint Petersburg, 195257

  • Dorozghnaya hospital

    Saint Petersburg, 195271

  • Clinical hospital of BGMU

    Ufa, 450081

  • Clinical emergency hospital #15

    Volgograd, 400026

  • Voronezh Regional Hospital N1

    Voronezh, 394066

  • Yaroslavl Regional Clin. Hospital

    Yaroslavl, 150062

  • Medical Center "Angioline"

    Yekaterinburg, 620063

  • LLC Medical Union New Hospital

    Yekaterinburg, 620109

Other trials in Russia

Italy16 sites

  • Clinica Villa dei Fiori

    Acerra, 80011

  • Ospedale san Lazzaro

    Alba, 15100

  • Policlinico di Bari

    Bari, 70100

  • P.O. di Castelfranco Veneto

    Castelfranco Veneto, 31033

  • Ospedale Civile degli Infermi

    Faenza (RA), 48022

  • Azienda Ospedaliera Vito Fazzi

    Lecce, 73100

  • Spedali Riuniti di Livorno

    Livorno, 57124

  • SUN Seconda Università Napoli

    Naples, 80138

  • Ospedale Gaetano Bernabeo

    Ortona (CH), 66026

  • Osp. Civico e Benfratelli "M. Ascoli e G. Di Cristina"

    Palermo, 90135

  • Ospedali Riuniti di Ancona

    Province of Macerata, 62100

  • Azienda Universitaria-Universita' La Sapienza

    Roma, 00161

  • Univ. Cattolica del Sacro Cuore

    Roma, 00168

  • Ospedale Civile

    Sassari, 07100

  • A. O. Ospedale Circolo Fond. Macchi

    Varese, 21100

  • A. O. Ospedale di Vimercate

    Vimercate (Mi), 20059

Other trials in Italy

Turkey (Türkiye)14 sites

  • Gazi University Medical Faculty

    Ankara, 06560

  • Ankara Atatürk Training and Research Hospital

    Ankara, 06800

  • Uludag University Medical Faculty

    Bursa, 16059

  • Dicle University Medical Faculty

    Diyarbakır, 21830

  • Dr. Ersin Arslan Public Hospital

    Gaziantep, 27010

  • Suleyman Demirel University Medical Faculty

    Isparta, 32260

  • Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Zuhura

    Istanbul, 34147

  • Medipol University Medical Faculty

    Istanbul, 34214

  • Izmir Tepecik Training and Research Hospital

    Izmir, 35520

  • Ege University Medical Faculty

    Izmir

  • Karaman Government Hospital

    Karaman

  • Kayseri Training And Research Hospital

    Kayseri, 38010

  • RTE University Medical Faculty

    Rize, 53200

  • Ozel Uzmanlar Yalova Hospital

    Yalova, 77200

Other trials in Turkey (Türkiye)

Czechia13 sites

  • Rehabilitacni nemocnice Beroun

    Beroun, 266 01

  • Diagangio s.r.o.

    Brno, 61200

  • University Hospital Brno

    Brno, 639 00

  • Nemocnice Milosrdnych bratri

    Brno, 63900

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • CTC Hodonin s.r.o.

    Hodonín, 695 01

  • MUDr. Ladislav Busak

    Louny, 440 01

  • MUDr. Stanislav Bulir

    Mladá Boleslav, 293 01

  • Nemocnice Náchod

    Náchod, 547 69

  • MUDr. Dalibor Musil

    Olomouc, 779 00

  • Fakultni nemocnice Plzen

    Pilsen, 305 99

  • Vseobecna fakultni nemocnice V Praze

    Prague, 128 08

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21

Other trials in Czechia

South Korea10 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A University Hospital

    Busan, 49201

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591

Other trials in South Korea

United Kingdom10 sites

  • Barnsley Hospital

    Barnsley, S75 2EP

  • North Hampshire Hospital

    Basingstoke, RG24 9NA

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Queen's Hospital

    Burton-on-Trent, DE13 0RB

  • University Hospital of North Durham

    Durham, DH1 5TW

  • St Thomas' Hospital

    London, SE1 7EH

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • North Tyneside General Hospital

    North Shields, NE29 8NH

  • Craigavon Area Hospital

    Portadown, BT63 5QQ

  • Salisbury District Hospital

    Salisbury, SP2 8BJ

Other trials in United Kingdom

Greece9 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • "Laiko" Hospital, 1st Vascular Surgery Clinic of UOA

    Athens, 11527

  • Athens Hospital of Chest Diseases "Sotiria"

    Athens, 11527

  • Gen. Hosp. of Chest Diseases "Sotiria", 3rd Internal Med. Cl

    Athens, 11527

  • University General Hospital Attikon

    Athens, 124 62

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

  • General University Hospital of Larissa

    Larissa, 41110

  • General Hospital of Athens "G. Gennimatas"

    Thessaloniki, 54635

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

Other trials in Greece

Hungary9 sites

  • Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat

    Balassagyarmat, 2660

  • St. Istvan Hospital, Budapest

    Budapest, 1096

  • Jahn Ferenc Del-Pest Hospital

    Budapest, 1204

  • University Debrecen Hospital

    Debrecen, 4032

  • Pest Megyei Flor Ferenc Hospital

    Kistarcsa, 2143

  • Dorottya Kanizsai Hospital

    Nagykanizsa, 8800

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Csongrad Country Dr Bugyi Istvan Hosp.

    Szentes, 6600

  • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet

    Szolnok, 5000

Other trials in Hungary

Serbia9 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Medical Center Zvezdara, Belgrade

    Belgrade, 11000

  • Institute for Cardiovascular diseases Dedinje

    Belgrade, 11000

  • General Hospital MediGroup

    Belgrade, 11070

  • Clinical Center Bezanijska kosa, Belgrade

    Belgrade, 11080

  • Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Centre Nis

    Niš, 18000

  • General Hospital Valjevo

    Valjevo, 14000

Other trials in Serbia

Lebanon7 sites

  • Clemenceau Medical Center

    Beirut, 11-2555

  • Rafik Hariri University Hospital

    Beirut, 5244

  • American University of Beirut Medical Center

    Beirut

  • Bellevue Medical Center

    Beirut

  • Centre Hospitalier Universitaire Notre Dame de Secours

    Byblos

  • Ain Wazein Hospital

    El-Chouf

  • Hammoud Hospital University Medical Center

    Saida, 652

Other trials in Lebanon

Colombia6 sites

  • Fundacion Cardiomet CEQUIN

    Armenia

  • Unidad de Investigaciones Clínicas

    Cali, 760032

  • Centro de Investigaciones Clinicas S.A.S

    Cali, 760036

  • Centro de Diagnostico Cardilogico

    Cartagena, 13001

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales, 170004

  • Promotora Medica Las Americas SA

    Medellín

Other trials in Colombia

Argentina5 sites

  • Hospital Universitario Austral

    Buenos Aires, B1629AHJ

  • Hospital Aleman

    CABA, 1118

  • Hospital Italiano

    CABA, 1181

  • ICBA

    CABA, 1428

  • Clinica Juncal

    Temperley, 1814

Other trials in Argentina

Egypt5 sites

  • Dr. Ashraf ElGhandour Private Clinic

    Alexandria, 21131

  • Private Clinic Dr. Mervat Mattar

    Cairo, 11322

  • Private Clinic Mohamed Moussa

    Cairo, 11341

  • Private Clinic - Dr. Shawky

    Cairo, 12345

  • Private Clinic - Dr. Ahmed Hassouna

    Kalyoub, 13632

Other trials in Egypt

Germany5 sites

  • Franziskus-Krankenhaus, Berlin

    Berlin, 10787

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • Praxis für Gefäßmedizin

    Görlitz, 02827

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Latvia5 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5420

  • Liepaja Regional Hospital, Therapy Department

    Liepāja, 3414

  • Riga East University Hospital

    Riga, 1038

  • VSV Centrs, Stalte Private Practice, Talsi

    Talsi, 3201

  • Gita Rancane Doctor Practice in Cardiology

    Ventspils, 3601

Other trials in Latvia

Slovakia5 sites

  • ALIAN s.r.o., Bardejov, Dzupinova, Maria

    Bardejov, 08501

  • KARDIO-ANGIO, s.r.o.

    Levice, 934 01

  • HeMart, s.r.o.

    Martin, 036 01

  • ABE-AS, s.r.o.

    Nitra, 949 01

  • MEDIVASA s.r.o., Outpatient Clinic, Zilina

    Žilina, 010 01

Other trials in Slovakia

Vietnam5 sites

  • Bach Mai hospital

    Hanoi, 100000

  • 115 People Hospital

    Ho Chi Minh City, 700000

  • Gia Dinh People Hospital

    Ho Chi Minh City, 700000

  • Cho Ray Hospital

    Ho Chi Minh City, 70000

  • University Medical Center of Ho Chi Minh City

    Ho Chi Minh City, 70000

Other trials in Vietnam

Belgium4 sites

  • ULB Hopital Erasme

    Brussels, 1070

  • C.H.U. de Charleroi

    Charleroi, 6000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • H.-Hartziekenhuis

    Lier, 2500

Other trials in Belgium

Bulgaria4 sites

  • UMHAT St. George

    Plovdiv, 4014

  • National Heart Hospital, Sofia

    Sofia, 1309

  • MHAT 'Tokuda Hospital Sofia', EAD

    Sofia, 1407

  • Hospital Trakia Park

    Stara Zagora, 6004

Other trials in Bulgaria

Mexico4 sites

  • Clinica Vascular de Guadalajara

    Guadalajara, 44670

  • Instituto Jalisciense de Metabolismo, SC

    Guadalajara, 44670

  • Hospital_Angeles Centro Médicodel Potosí

    San Luis Potosí City, 78200

  • Arke Estudios Clinicos SA de CV

    Veracruz, 91910

Other trials in Mexico

Netherlands4 sites

  • OLVG, locatie Oosterpark

    Amsterdam, 1091 AC

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Tweesteden Ziekenhuis, locatie Tilburg

    Tilburg, 5042 AD

Other trials in Netherlands

Poland4 sites

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 4

    Bytom, 41-902

  • Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego

    Ostrołęka, 07-410

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981

Other trials in Poland

Portugal4 sites

  • Hospital Ponta Delgada

    Ponta Delgada, 9500-370

  • Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

    Porto, 4099-001

  • Hospital CUF Porto

    Porto, 4100-180

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4400-129

Other trials in Portugal

Slovenia4 sites

  • GH Celje

    Celje, 3000

  • Univ. Clinic of Respiratory and Allergic Diseases, Golnik

    Golnik, 4204

  • UCC Maribor

    Maribor, 2000

  • Hospital Topolsica

    Topolšica, 3326

Other trials in Slovenia

Austria3 sites

  • LKH Feldkirch

    Feldkirch, 6807

  • LKH-Univ. Hospital Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

Other trials in Austria

Brazil3 sites

  • Hospital Vera Cruz

    Belo Horizonte, 30140-092

  • Faculdade de Ciencias Medicas da UNICAMP

    Campinas, 13083970

  • Hospital das Clinicas da Faculdade de Medicina - FMUSP

    São Paulo, 05403-000

Other trials in Brazil

Philippines3 sites

  • Makati Medical Center

    Makati, 1229

  • Philippine General Hospital

    Manila, Philippines, 1000

  • St. Luke's Medical Center, QC

    Quezon City, 1400

Other trials in Philippines

Romania3 sites

  • Private Practice Cardiology Dr. Pop Calin Florin

    Baia Mare, 430123

  • Emergency University Hospital, Bucharest

    Bucharest, 050098

  • Spitalul Clinic Municipal Cluj Napoca

    Cluj-Napoca, 400136

Other trials in Romania

Thailand3 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Thammasat University Hospital

    Pathum Tani, 12120

Other trials in Thailand

Canada2 sites

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Juravinski Hospital - Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C3

Other trials in Canada

Malaysia2 sites

  • Hospital Raja Perempuan Zainab II, Kota Bharu

    Kota Bharu, 15586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Chile1 site

  • SMOLAM

    Santiago, 7500922

Other trials in Chile

New Zealand1 site

  • Palmerston North Hospital

    Palmerston North, 4442

Other trials in New Zealand

Peru1 site

  • Centro Medico Piura

    Piura, 51

Other trials in Peru

Saudi Arabia1 site

  • King Fahad Medical City

    Riyadh, 11525

Other trials in Saudi Arabia

United Arab Emirates1 site

  • Thumbay Hospital

    Dubai, 41840

Other trials in United Arab Emirates

About this study

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

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.

Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02596230
Study groupRoleWhat they receive
Patients with acute VTEPatients will be enrolled for cross sectional characterization of baseline characteristics
DabigatranPatients treated with dabigatran for acute VTE will be followed for one year
vitamin K antagonistPatients treated with VKA for acute VTE will be followed for one year

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study start5 Nov 2015
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7,797 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596230
Sponsor's protocol ID
1160.188
Status last verified
Apr 2020
First submitted
28 Oct 2015
Last updated
29 Apr 2020
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 222 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States, Russia, Italy, Turkey (Türkiye), Czechia and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective 1: Age (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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02596230, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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