Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00291330




Registration number
NCT00291330
Ethics application status
Date submitted
13/02/2006
Date registered
14/02/2006
Date last updated
6/06/2014

Titles & IDs
Public title
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Scientific title
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
Secondary ID [1] 0 0
2005-001999-12
Secondary ID [2] 0 0
1160.53
Universal Trial Number (UTN)
Trial acronym
RE-COVER I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate 150 mg
Treatment: Drugs - warfarin (INR 2-3)

Experimental: dabigatran etexilate 150 mg - twice daily

Active comparator: warfarin (INR 2-3) - prn to maintain INR (2-3)


Treatment: Drugs: dabigatran etexilate 150 mg
twice daily

Treatment: Drugs: warfarin (INR 2-3)
prn to maintain INR (2-3)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
Timepoint [1] 0 0
For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
Secondary outcome [1] 0 0
Number of Participants With Recurrent Symptomatic VTE and All Deaths
Timepoint [1] 0 0
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Secondary outcome [2] 0 0
Number of Participants With Recurrent Symptomatic DVT
Timepoint [2] 0 0
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Secondary outcome [3] 0 0
Number of Participants With Recurrent Symptomatic Non-fatal PE
Timepoint [3] 0 0
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Secondary outcome [4] 0 0
Number of Participants Who Died Due to VTE
Timepoint [4] 0 0
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Secondary outcome [5] 0 0
Number of Participants Who Died (Any Cause)
Timepoint [5] 0 0
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Secondary outcome [6] 0 0
Number of Participants With Bleeding Events
Timepoint [6] 0 0
From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
Secondary outcome [7] 0 0
Number of Participants With Acute Coronary Syndrome (ACS)
Timepoint [7] 0 0
From first intake of study drug to end of study conduct
Secondary outcome [8] 0 0
Laboratory Analyses
Timepoint [8] 0 0
From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)

Eligibility
Key inclusion criteria
Inclusion criteria

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT > 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
2564
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.53.61002 Boehringer Ingelheim Investigational Site - Woolloongabba
Recruitment hospital [2] 0 0
1160.53.61004 Boehringer Ingelheim Investigational Site - Bedford Park
Recruitment hospital [3] 0 0
1160.53.61003 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [4] 0 0
1160.53.61001 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [5] 0 0
1160.53.61006 The Avenue Cardiovascular Centre - Windsor
Recruitment hospital [6] 0 0
1160.53.61005 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Windsor
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Argentina
State/province [18] 0 0
Adrogué
Country [19] 0 0
Argentina
State/province [19] 0 0
Capital Federal
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbruck
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussel
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles
Country [25] 0 0
Belgium
State/province [25] 0 0
Edegem
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Belgium
State/province [27] 0 0
Liège
Country [28] 0 0
Brazil
State/province [28] 0 0
Brasília
Country [29] 0 0
Brazil
State/province [29] 0 0
Campinas
Country [30] 0 0
Brazil
State/province [30] 0 0
Cerqueira César - Sao Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
Cerqueira César - São Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Cristo Rei - Curitiba
Country [33] 0 0
Brazil
State/province [33] 0 0
Goiânia -
Country [34] 0 0
Brazil
State/province [34] 0 0
Paraná -
Country [35] 0 0
Brazil
State/province [35] 0 0
Porto Alegre
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio de Janeiro - RJ
Country [37] 0 0
Brazil
State/province [37] 0 0
Santo André
Country [38] 0 0
Brazil
State/province [38] 0 0
São José do Rio Preto
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
New Brunswick
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Brno
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Hranice
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Jihlava
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Liberec
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Novy Jicin
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Ostrava-Vitkovice
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Praha 2
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Tabor
Country [54] 0 0
Czech Republic
State/province [54] 0 0
Teplice
Country [55] 0 0
Czech Republic
State/province [55] 0 0
Usti nad Labem
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Zlin
Country [57] 0 0
Denmark
State/province [57] 0 0
Esbjerg
Country [58] 0 0
Denmark
State/province [58] 0 0
Holbæk
Country [59] 0 0
Denmark
State/province [59] 0 0
Kolding
Country [60] 0 0
Denmark
State/province [60] 0 0
København NV
Country [61] 0 0
Denmark
State/province [61] 0 0
København S
Country [62] 0 0
Denmark
State/province [62] 0 0
Slagelse
Country [63] 0 0
France
State/province [63] 0 0
Brest Cedex
Country [64] 0 0
France
State/province [64] 0 0
Lorient
Country [65] 0 0
France
State/province [65] 0 0
Montpellier Cedex 5
Country [66] 0 0
France
State/province [66] 0 0
Nancy
Country [67] 0 0
France
State/province [67] 0 0
St Etienne Cedex 2
Country [68] 0 0
France
State/province [68] 0 0
St Priest en Jarez
Country [69] 0 0
France
State/province [69] 0 0
Toulon Naval
Country [70] 0 0
France
State/province [70] 0 0
Vandoeuvre les Nancy
Country [71] 0 0
Germany
State/province [71] 0 0
Dresden
Country [72] 0 0
Germany
State/province [72] 0 0
Köln
Country [73] 0 0
Germany
State/province [73] 0 0
Mannheim
Country [74] 0 0
Germany
State/province [74] 0 0
München
Country [75] 0 0
Germany
State/province [75] 0 0
Püttlingen
Country [76] 0 0
Greece
State/province [76] 0 0
Athens
Country [77] 0 0
Hungary
State/province [77] 0 0
Budapest
Country [78] 0 0
Hungary
State/province [78] 0 0
Debrecen
Country [79] 0 0
Hungary
State/province [79] 0 0
Eger
Country [80] 0 0
Hungary
State/province [80] 0 0
Gyula
Country [81] 0 0
Hungary
State/province [81] 0 0
Miskolc
Country [82] 0 0
Hungary
State/province [82] 0 0
Pecs
Country [83] 0 0
Hungary
State/province [83] 0 0
Szombathely
Country [84] 0 0
Hungary
State/province [84] 0 0
Székesfehérvár
Country [85] 0 0
India
State/province [85] 0 0
Bangalore
Country [86] 0 0
India
State/province [86] 0 0
Chennai
Country [87] 0 0
India
State/province [87] 0 0
Indore
Country [88] 0 0
India
State/province [88] 0 0
Karna
Country [89] 0 0
India
State/province [89] 0 0
Kerala
Country [90] 0 0
India
State/province [90] 0 0
Ludhiana
Country [91] 0 0
India
State/province [91] 0 0
Mysore
Country [92] 0 0
India
State/province [92] 0 0
Nagpur
Country [93] 0 0
India
State/province [93] 0 0
New Delhi
Country [94] 0 0
India
State/province [94] 0 0
Pune
Country [95] 0 0
India
State/province [95] 0 0
Vadodara
Country [96] 0 0
Israel
State/province [96] 0 0
Afula
Country [97] 0 0
Israel
State/province [97] 0 0
Ashkelon
Country [98] 0 0
Israel
State/province [98] 0 0
Haifa
Country [99] 0 0
Israel
State/province [99] 0 0
Holon
Country [100] 0 0
Israel
State/province [100] 0 0
KfarSaba
Country [101] 0 0
Israel
State/province [101] 0 0
Petah Tiqwa
Country [102] 0 0
Israel
State/province [102] 0 0
Tel Hashomer
Country [103] 0 0
Israel
State/province [103] 0 0
Tel-Aviv
Country [104] 0 0
Israel
State/province [104] 0 0
Zerifin
Country [105] 0 0
Italy
State/province [105] 0 0
Bologna
Country [106] 0 0
Italy
State/province [106] 0 0
Padova
Country [107] 0 0
Italy
State/province [107] 0 0
Perugia
Country [108] 0 0
Italy
State/province [108] 0 0
Reggio Emilia
Country [109] 0 0
Italy
State/province [109] 0 0
Vimercate
Country [110] 0 0
Italy
State/province [110] 0 0
Vittorio Veneto (tv)
Country [111] 0 0
Mexico
State/province [111] 0 0
Chihuahua
Country [112] 0 0
Mexico
State/province [112] 0 0
Culiacan
Country [113] 0 0
Mexico
State/province [113] 0 0
San Luis Potosí
Country [114] 0 0
Netherlands
State/province [114] 0 0
's Hertogenbosch
Country [115] 0 0
Netherlands
State/province [115] 0 0
Amersfoort
Country [116] 0 0
Netherlands
State/province [116] 0 0
Amsterdam
Country [117] 0 0
Netherlands
State/province [117] 0 0
Eindhoven
Country [118] 0 0
Netherlands
State/province [118] 0 0
Maastricht
Country [119] 0 0
Netherlands
State/province [119] 0 0
Nieuwegein
Country [120] 0 0
Netherlands
State/province [120] 0 0
Rotterdam
Country [121] 0 0
New Zealand
State/province [121] 0 0
Auckland
Country [122] 0 0
New Zealand
State/province [122] 0 0
Christchurch
Country [123] 0 0
New Zealand
State/province [123] 0 0
Otahuhu Auckland
Country [124] 0 0
New Zealand
State/province [124] 0 0
Takapuna Auckland
Country [125] 0 0
Norway
State/province [125] 0 0
Oslo
Country [126] 0 0
Norway
State/province [126] 0 0
Rud
Country [127] 0 0
Norway
State/province [127] 0 0
Trondheim
Country [128] 0 0
Portugal
State/province [128] 0 0
Almada
Country [129] 0 0
Portugal
State/province [129] 0 0
Coimbra
Country [130] 0 0
Portugal
State/province [130] 0 0
Lisboa
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Chelyabinsk
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Ekaterinburg
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Krasnodar
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Kursk
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Moscow
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Novosibirsk
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Omsk
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Pskov
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Rostov-na-Donu
Country [140] 0 0
Russian Federation
State/province [140] 0 0
St. Petersburg
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Ufa
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Yaroslavl
Country [143] 0 0
Slovakia
State/province [143] 0 0
Banska Bystrica
Country [144] 0 0
Slovakia
State/province [144] 0 0
Lucenec
Country [145] 0 0
Slovakia
State/province [145] 0 0
Nitra
Country [146] 0 0
Slovakia
State/province [146] 0 0
Nove Zamky
Country [147] 0 0
Slovakia
State/province [147] 0 0
Zilina
Country [148] 0 0
South Africa
State/province [148] 0 0
Centurion
Country [149] 0 0
South Africa
State/province [149] 0 0
Johannesburg
Country [150] 0 0
South Africa
State/province [150] 0 0
Pretoria
Country [151] 0 0
South Africa
State/province [151] 0 0
Randburg
Country [152] 0 0
South Africa
State/province [152] 0 0
Richards Bay
Country [153] 0 0
South Africa
State/province [153] 0 0
Roodepoort
Country [154] 0 0
Spain
State/province [154] 0 0
Badalona (Barcelona)
Country [155] 0 0
Spain
State/province [155] 0 0
Barcelona
Country [156] 0 0
Spain
State/province [156] 0 0
Cartagena. Murcia
Country [157] 0 0
Spain
State/province [157] 0 0
Cuenca
Country [158] 0 0
Spain
State/province [158] 0 0
Madrid
Country [159] 0 0
Spain
State/province [159] 0 0
Santander
Country [160] 0 0
Spain
State/province [160] 0 0
Torrelavega.Santander
Country [161] 0 0
Spain
State/province [161] 0 0
Valencia
Country [162] 0 0
Sweden
State/province [162] 0 0
Göteborg
Country [163] 0 0
Sweden
State/province [163] 0 0
Jönköping
Country [164] 0 0
Sweden
State/province [164] 0 0
Stockholm
Country [165] 0 0
Sweden
State/province [165] 0 0
Sundsvall
Country [166] 0 0
Sweden
State/province [166] 0 0
Uppsala
Country [167] 0 0
Turkey
State/province [167] 0 0
Ankara
Country [168] 0 0
Turkey
State/province [168] 0 0
Istanbul
Country [169] 0 0
Turkey
State/province [169] 0 0
Izmir
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kiev
Country [171] 0 0
Ukraine
State/province [171] 0 0
Vinnitsa
Country [172] 0 0
Ukraine
State/province [172] 0 0
Zaporozhye
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Aberdeen
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Headington, Oxford
Country [175] 0 0
United Kingdom
State/province [175] 0 0
London
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Newcastle upon Tyne
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00291330