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

NCT ID: NCT02596230

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7797 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-05
• Study Completion Date: 2019-03-31

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.

Conditions

Venous Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with acute VTE

Patients will be enrolled for cross sectional characterization of baseline characteristics

No interventions assigned to this group

Dabigatran

Patients treated with dabigatran for acute VTE will be followed for one year

No interventions assigned to this group

vitamin K antagonist

Patients treated with VKA for acute VTE will be followed for one year

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Cardiovascular Innovation and Research Center

Long Beach, California, United States

Health and Life Research Institute, LLC

Miami, Florida, United States

Med-Care Research

Miami, Florida, United States

Pines Care Research Center

Pembroke Pines, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Ellipsis Group

Atlanta, Georgia, United States

Wellstar Cardiovascular Medicine

Marietta, Georgia, United States

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

University Of Mississippi Medical Center

Jackson, Mississippi, United States

Vidant Multispecialty Clnc Kinston

Kinston, North Carolina, United States

Sanford Cardiology

Sanford, North Carolina, United States

Lycoming Internal Medicine, Inc

Jersey Shore, Pennsylvania, United States

Research Associates of Jackson

Jackson, Tennessee, United States

The University Of Texas at Houston

Houston, Texas, United States

Cardiology Center of Houston, PA

Katy, Texas, United States

Cardio Voyage

McKinney, Texas, United States

Waukesha Heart Institute

Waukesha, Wisconsin, United States

Hospital Universitario Austral

Buenos Aires, , Argentina

Hospital Aleman

CABA, , Argentina

Hospital Italiano

CABA, , Argentina

ICBA

CABA, , Argentina

Clinica Juncal

Temperley, , Argentina

LKH Feldkirch

Feldkirch, , Austria

LKH-Univ. Hospital Graz

Graz, , Austria

Medical University of Innsbruck

Innsbruck, , Austria

ULB Hopital Erasme

Brussels, , Belgium

C.H.U. de Charleroi

Charleroi, , Belgium

H.-Hartziekenhuis

Lier, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Hospital Vera Cruz

Belo Horizonte, , Brazil

Faculdade de Ciencias Medicas da UNICAMP

Campinas, , Brazil

Hospital das Clinicas da Faculdade de Medicina - FMUSP

São Paulo, , Brazil

UMHAT St. George

Plovdiv, , Bulgaria

National Heart Hospital, Sofia

Sofia, , Bulgaria

MHAT 'Tokuda Hospital Sofia', EAD

Sofia, , Bulgaria

Hospital Trakia Park

Stara Zagora, , Bulgaria

Hamilton General Hospital

Hamilton, Ontario, Canada

Juravinski Hospital - Hamilton Health Sciences

Hamilton, Ontario, Canada

SMOLAM

Santiago, , Chile

Fundacion Cardiomet CEQUIN

Armenia, , Colombia

Unidad de Investigaciones Clínicas

Cali, , Colombia

Centro de Investigaciones Clinicas S.A.S

Cali, , Colombia

Centro de Diagnostico Cardilogico

Cartagena, , Colombia

Asociacion IPS Medicos Internistas de Caldas

Manizales, , Colombia

Promotora Medica Las Americas SA

Medellín, , Colombia

Rehabilitacni nemocnice Beroun

Beroun, , Czechia

Diagangio s.r.o.

Brno, , Czechia

University Hospital Brno

Brno, , Czechia

Nemocnice Milosrdnych bratri

Brno, , Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

CTC Hodonin s.r.o.

Hodonín, , Czechia

MUDr. Ladislav Busak

Louny, , Czechia

MUDr. Stanislav Bulir

Mladá Boleslav, , Czechia

Nemocnice Náchod

Náchod, , Czechia

MUDr. Dalibor Musil

Olomouc, , Czechia

Fakultni nemocnice Plzen

Pilsen, , Czechia

Vseobecna fakultni nemocnice V Praze

Prague, , Czechia

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Dr. Ashraf ElGhandour Private Clinic

Alexandria, , Egypt

Private Clinic Dr. Mervat Mattar

Cairo, , Egypt

Private Clinic Mohamed Moussa

Cairo, , Egypt

Private Clinic - Dr. Shawky

Cairo, , Egypt

Private Clinic - Dr. Ahmed Hassouna

Kalyoub, , Egypt

Franziskus-Krankenhaus, Berlin

Berlin, , Germany

Städtisches Klinikum Dresden

Dresden, , Germany

Praxis für Gefäßmedizin

Görlitz, , Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

University Hospital of Alexandroupolis

Alexandroupoli, , Greece

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

Athens, , Greece

Athens Hospital of Chest Diseases "Sotiria"

Athens, , Greece

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

Athens, , Greece

University General Hospital Attikon

Athens, , Greece

Univ. Gen. Hosp. of Ioannina

Ioannina, , Greece

General University Hospital of Larissa

Larissa, , Greece

General Hospital of Athens "G. Gennimatas"

Thessaloniki, , Greece

University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat

Balassagyarmat, , Hungary

St. Istvan Hospital, Budapest

Budapest, , Hungary

Jahn Ferenc Del-Pest Hospital

Budapest, , Hungary

University Debrecen Hospital

Debrecen, , Hungary

Pest Megyei Flor Ferenc Hospital

Kistarcsa, , Hungary

Dorottya Kanizsai Hospital

Nagykanizsa, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Csongrad Country Dr Bugyi Istvan Hosp.

Szentes, , Hungary

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

Szolnok, , Hungary

Clinica Villa dei Fiori

Acerra, , Italy

Ospedale san Lazzaro

Alba, , Italy

Policlinico di Bari

Bari, , Italy

P.O. di Castelfranco Veneto

Castelfranco Veneto, , Italy

Ospedale Civile degli Infermi

Faenza (RA), , Italy

Azienda Ospedaliera Vito Fazzi

Lecce, , Italy

Spedali Riuniti di Livorno

Livorno, , Italy

Ospedali Riuniti di Ancona

Macerata, , Italy

SUN Seconda Università Napoli

Napoli, , Italy

Ospedale Gaetano Bernabeo

Ortona (CH), , Italy

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

Palermo, , Italy

Azienda Universitaria-Universita' La Sapienza

Roma, , Italy

Univ. Cattolica del Sacro Cuore

Roma, , Italy

Ospedale Civile

Sassari, , Italy

A. O. Ospedale Circolo Fond. Macchi

Varese, , Italy

A. O. Ospedale di Vimercate

Vimercate (Mi), , Italy

Daugavpils Regional Hospital

Daugavpils, , Latvia

Liepaja Regional Hospital, Therapy Department

Liepāja, , Latvia

Riga East University Hospital

Riga, , Latvia

VSV Centrs, Stalte Private Practice, Talsi

Talsi, , Latvia

Gita Rancane Doctor Practice in Cardiology

Ventspils, , Latvia

Clemenceau Medical Center

Beirut, , Lebanon

Rafik Hariri University Hospital

Beirut, , Lebanon

American University of Beirut Medical Center

Beirut, , Lebanon

Bellevue Medical Center

Beirut, , Lebanon

Centre Hospitalier Universitaire Notre Dame de Secours

Byblos, , Lebanon

Ain Wazein Hospital

El-Chouf, , Lebanon

Hammoud Hospital University Medical Center

Saida, , Lebanon

Hospital Raja Perempuan Zainab II, Kota Bharu

Kota Bharu, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Clinica Vascular de Guadalajara

Guadalajara, , Mexico

Instituto Jalisciense de Metabolismo, SC

Guadalajara, , Mexico

Hospital_Angeles Centro Médicodel Potosí

San Luis Potosí City, , Mexico

Arke Estudios Clinicos SA de CV

Veracruz, , Mexico

OLVG, locatie Oosterpark

Amsterdam, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , Netherlands

Tweesteden Ziekenhuis, locatie Tilburg

Tilburg, , Netherlands

Palmerston North Hospital

Palmerston North, , New Zealand

Centro Medico Piura

Piura, , Peru

Makati Medical Center

Makati, , Philippines

Philippine General Hospital

Manila, Philippines, , Philippines

St. Luke's Medical Center, QC

Quezon City, , Philippines

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, , Poland

SPZOZ Wojewodzki Szpital Specjalistyczny nr 4

Bytom, , Poland

Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego

Ostrołęka, , Poland

4. Military Clinical Hospital with Polyclinic SP ZOZ

Wroclaw, , Poland

Hospital Ponta Delgada

Ponta Delgada, , Portugal

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

Porto, , Portugal

Hospital CUF Porto

Porto, , Portugal

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Private Practice Cardiology Dr. Pop Calin Florin

Baia Mare, , Romania

Emergency University Hospital, Bucharest

Bucharest, , Romania

Spitalul Clinic Municipal Cluj Napoca

Cluj-Napoca, , Romania

Regional Clinical Hospital#3

Chelyabinsk, , Russia

State Autonomous Institution of Health

Kemerovo, , Russia

Hospital #15 named after O.M.Filatov

Moscow, , Russia

Federal Research and Clinical Center of Special Medical Help

Moscow, , Russia

City Clinical Hospital 1 (1-Gradskaya)

Moscow, , Russia

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

Moscow, , Russia

Novosibirsk Research Institute

Novosibirsk, , Russia

Rostov Medical University

Rostov-on-Don, , Russia

City Clinical Hospital No. 2, St. Petersburg

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

City Hospital Saint Elizaveta, Dept. Endocrinology

Saint Petersburg, , Russia

Dorozghnaya hospital

Saint Petersburg, , Russia

Clinical hospital of BGMU

Ufa, , Russia

Clinical emergency hospital #15

Volgograd, , Russia

Voronezh Regional Hospital N1

Voronezh, , Russia

Yaroslavl Regional Clin. Hospital

Yaroslavl, , Russia

Medical Center "Angioline"

Yekaterinburg, , Russia

LLC Medical Union New Hospital

Yekaterinburg, , Russia

King Fahad Medical City

Riyadh, , Saudi Arabia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Medical Center Zvezdara, Belgrade

Belgrade, , Serbia

Institute for Cardiovascular diseases Dedinje

Belgrade, , Serbia

General Hospital MediGroup

Belgrade, , Serbia

Clinical Center Bezanijska kosa, Belgrade

Belgrade, , Serbia

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

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Centre Nis

Niš, , Serbia

General Hospital Valjevo

Valjevo, , Serbia

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

Bardejov, , Slovakia

KARDIO-ANGIO, s.r.o.

Levice, , Slovakia

HeMart, s.r.o.

Martin, , Slovakia

ABE-AS, s.r.o.

Nitra, , Slovakia

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

Žilina, , Slovakia

GH Celje

Celje, , Slovenia

Univ. Clinic of Respiratory and Allergic Diseases, Golnik

Golnik, , Slovenia

UCC Maribor

Maribor, , Slovenia

Hospital Topolsica

Topolšica, , Slovenia

Hallym University Sacred Heart Hospital

Anyang-si, , South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Dong-A University Hospital

Busan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Soonchunhyang University Hospital Seoul

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

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

Seoul, , South Korea

Phramongkutklao Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Thammasat University Hospital

Pathum Tani, , Thailand

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara Atatürk Training and Research Hospital

Ankara, , Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Dicle University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Dr. Ersin Arslan Public Hospital

Gaziantep, , Turkey (Türkiye)

Suleyman Demirel University Medical Faculty

Isparta, , Turkey (Türkiye)

Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Zuhura

Istanbul, , Turkey (Türkiye)

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Izmir Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Karaman Government Hospital

Karaman, , Turkey (Türkiye)

Kayseri Training And Research Hospital

Kayseri, , Turkey (Türkiye)

RTE University Medical Faculty

Rize, , Turkey (Türkiye)

Ozel Uzmanlar Yalova Hospital

Yalova, , Turkey (Türkiye)

Thumbay Hospital

Dubai, , United Arab Emirates

Barnsley Hospital

Barnsley, , United Kingdom

North Hampshire Hospital

Basingstoke, , United Kingdom

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Queen's Hospital

Burton-on-Trent, , United Kingdom

University Hospital of North Durham

Durham, , United Kingdom

St Thomas' Hospital

London, , United Kingdom

Wythenshawe Hospital

Manchester, , United Kingdom

North Tyneside General Hospital

North Shields, , United Kingdom

Craigavon Area Hospital

Portadown, , United Kingdom

Salisbury District Hospital

Salisbury, , United Kingdom

Bach Mai hospital

Hanoi, , Vietnam

115 People Hospital

Ho Chi Minh City, , Vietnam

Gia Dinh People Hospital

Ho Chi Minh City, , Vietnam

Cho Ray Hospital

Ho Chi Minh City, , Vietnam

University Medical Center of Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Countries

United States; Argentina; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; Colombia; Czechia; Egypt; Germany; Greece; Hungary; Italy; Latvia; Lebanon; Malaysia; Mexico; Netherlands; New Zealand; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia; Slovakia; Slovenia; South Korea; Thailand; Turkey (Türkiye); United Arab Emirates; United Kingdom; Vietnam

References

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.

Reference Type: DERIVED

PMID: 34453675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32851572 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32325043 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1160.188

Identifier Type: -

Identifier Source: org_study_id