Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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/NCT00329238




Registration number
NCT00329238
Ethics application status
Date submitted
23/05/2006
Date registered
24/05/2006
Date last updated
19/05/2014

Titles & IDs
Public title
Secondary Prevention of Venous Thrombo Embolism (VTE).
Scientific title
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Secondary ID [1] 0 0
2005-002536-94
Secondary ID [2] 0 0
1160.47
Universal Trial Number (UTN)
Trial acronym
RE-MEDY
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
Treatment: Drugs - Warfarin

Experimental: Dabigatran - Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements

Active comparator: Warfarin (INR of 2.0-3.0) - Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily


Treatment: Drugs: Dabigatran
Dabigatran 150 mg BID (twice daily)

Treatment: Drugs: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Recurrent VTE or VTE Death at 36 Months
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Composite of Recurrent VTE or VTE Death at 18 Months
Timepoint [2] 0 0
18 months
Secondary outcome [1] 0 0
Composite of Recurrent VTE or All Cause Death at 36 Months
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Composite of Recurrent VTE or All Cause Death at 18 Months
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Deep Vein Thrombosis (DVT) at 36 Months
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
DVT at 18 Months
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Symptomatic Pulmonary Embolism (PE) at 36 Months
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Symptomatic Pulmonary Embolism (PE) at 18 Months
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Deaths Related to VTE at 36 Months
Timepoint [7] 0 0
36 months
Secondary outcome [8] 0 0
Deaths Related to VTE at 18 Months
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Deaths of All Causes at 36 Months
Timepoint [9] 0 0
36 months
Secondary outcome [10] 0 0
Deaths of All Causes at 18 Months
Timepoint [10] 0 0
18 months
Secondary outcome [11] 0 0
Number of Participants With Bleeding Events
Timepoint [11] 0 0
first intake of study drug until 6 days following last intake of study drug
Secondary outcome [12] 0 0
Laboratory Analysis
Timepoint [12] 0 0
18 months + 30 days follow up
Secondary outcome [13] 0 0
Number of Participants With Definite Acute Coronary Syndrome (ACS)
Timepoint [13] 0 0
day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

Eligibility
Key inclusion criteria
Inclusion criteria:

Inclusion_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Exclusion_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
* Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

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
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
2867
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.47.61002 Princess Alexandra Hospital - Wooloongabba
Recruitment hospital [2] 0 0
1160.47.61004 Boehringer Ingelheim Investigational Site - Bedford Park
Recruitment hospital [3] 0 0
1160.47.61003 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [4] 0 0
1160.47.61001 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [5] 0 0
1160.47.61006 Boehringer Ingelheim Investigational Site - Windsor
Recruitment hospital [6] 0 0
1160.47.61005 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Wooloongabba
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
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
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
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Adrogué
Country [18] 0 0
Argentina
State/province [18] 0 0
Bahía Blanca
Country [19] 0 0
Argentina
State/province [19] 0 0
Capital Federal
Country [20] 0 0
Argentina
State/province [20] 0 0
La Plata
Country [21] 0 0
Argentina
State/province [21] 0 0
Mar del Plata
Country [22] 0 0
Argentina
State/province [22] 0 0
Quilmes
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Argentina
State/province [24] 0 0
Salta
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Austria
State/province [26] 0 0
Graz
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Belgium
State/province [29] 0 0
Bruxelles
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Belgium
State/province [31] 0 0
Liège
Country [32] 0 0
Brazil
State/province [32] 0 0
Brasília
Country [33] 0 0
Brazil
State/province [33] 0 0
Campinas - SP
Country [34] 0 0
Brazil
State/province [34] 0 0
Curitiba
Country [35] 0 0
Brazil
State/province [35] 0 0
Juvene - Paraná -
Country [36] 0 0
Brazil
State/province [36] 0 0
pTO aLEGRE
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro - RJ
Country [38] 0 0
Brazil
State/province [38] 0 0
São Bernardo do Campo
Country [39] 0 0
Brazil
State/province [39] 0 0
São José do Rio Preto
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Plovdiv
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Rousse
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Sofia
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Varna
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
British Columbia
Country [46] 0 0
Canada
State/province [46] 0 0
New Brunswick
Country [47] 0 0
Canada
State/province [47] 0 0
Nova Scotia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
China
State/province [50] 0 0
Beijing
Country [51] 0 0
China
State/province [51] 0 0
Chengdu
Country [52] 0 0
China
State/province [52] 0 0
Guangzhou
Country [53] 0 0
China
State/province [53] 0 0
Hangzhou
Country [54] 0 0
China
State/province [54] 0 0
Nanjing
Country [55] 0 0
China
State/province [55] 0 0
Shanghai
Country [56] 0 0
China
State/province [56] 0 0
Shijiazhuang
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Brno
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Hradec Kralove
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Hranice
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Liberec
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Novy Jicin
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Ostrava-Vitkovice
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Praha 2
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Tabor
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Usti nad Labem
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Zlin
Country [67] 0 0
Denmark
State/province [67] 0 0
Esbjerg
Country [68] 0 0
Denmark
State/province [68] 0 0
Holbæk
Country [69] 0 0
Denmark
State/province [69] 0 0
Kolding
Country [70] 0 0
Denmark
State/province [70] 0 0
København NV
Country [71] 0 0
Denmark
State/province [71] 0 0
København S
Country [72] 0 0
Denmark
State/province [72] 0 0
Slagelse
Country [73] 0 0
Finland
State/province [73] 0 0
Espoo
Country [74] 0 0
Finland
State/province [74] 0 0
Helsinki
Country [75] 0 0
Finland
State/province [75] 0 0
Jyväskylä
Country [76] 0 0
Finland
State/province [76] 0 0
Kuopio
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
France
State/province [78] 0 0
Brest Cedex
Country [79] 0 0
France
State/province [79] 0 0
Lorient
Country [80] 0 0
France
State/province [80] 0 0
St Etienne Cedex 2
Country [81] 0 0
France
State/province [81] 0 0
Vandoeuvre les Nancy
Country [82] 0 0
Germany
State/province [82] 0 0
Dresden
Country [83] 0 0
Germany
State/province [83] 0 0
Köln
Country [84] 0 0
Germany
State/province [84] 0 0
Mannheim
Country [85] 0 0
Germany
State/province [85] 0 0
München
Country [86] 0 0
Germany
State/province [86] 0 0
Püttlingen
Country [87] 0 0
Greece
State/province [87] 0 0
Athens
Country [88] 0 0
Hungary
State/province [88] 0 0
Budapest
Country [89] 0 0
Hungary
State/province [89] 0 0
Debrecen
Country [90] 0 0
Hungary
State/province [90] 0 0
Gyula
Country [91] 0 0
Hungary
State/province [91] 0 0
Miskolc
Country [92] 0 0
Hungary
State/province [92] 0 0
Pecs
Country [93] 0 0
Hungary
State/province [93] 0 0
Szombathely
Country [94] 0 0
Hungary
State/province [94] 0 0
Székesfehérvár
Country [95] 0 0
India
State/province [95] 0 0
Ahmedabad
Country [96] 0 0
India
State/province [96] 0 0
Bangalore
Country [97] 0 0
India
State/province [97] 0 0
Chennai
Country [98] 0 0
India
State/province [98] 0 0
Madurai
Country [99] 0 0
India
State/province [99] 0 0
Mysore
Country [100] 0 0
India
State/province [100] 0 0
New Delhi
Country [101] 0 0
India
State/province [101] 0 0
new Delhi
Country [102] 0 0
India
State/province [102] 0 0
Pune
Country [103] 0 0
India
State/province [103] 0 0
Trivandrum
Country [104] 0 0
India
State/province [104] 0 0
Vadodara
Country [105] 0 0
Israel
State/province [105] 0 0
Afula
Country [106] 0 0
Israel
State/province [106] 0 0
Ashkelon
Country [107] 0 0
Israel
State/province [107] 0 0
Haifa
Country [108] 0 0
Israel
State/province [108] 0 0
Holon
Country [109] 0 0
Israel
State/province [109] 0 0
Kfar Saba
Country [110] 0 0
Israel
State/province [110] 0 0
Petach Tikva
Country [111] 0 0
Israel
State/province [111] 0 0
Rehovot
Country [112] 0 0
Israel
State/province [112] 0 0
Tel Aviv
Country [113] 0 0
Israel
State/province [113] 0 0
Tel Hashomer
Country [114] 0 0
Israel
State/province [114] 0 0
Zerifin
Country [115] 0 0
Italy
State/province [115] 0 0
Bologna
Country [116] 0 0
Italy
State/province [116] 0 0
Cremona
Country [117] 0 0
Italy
State/province [117] 0 0
Genova
Country [118] 0 0
Italy
State/province [118] 0 0
Milano
Country [119] 0 0
Italy
State/province [119] 0 0
Reggio Emilia
Country [120] 0 0
Italy
State/province [120] 0 0
Udine
Country [121] 0 0
Italy
State/province [121] 0 0
Vittorio Veneto
Country [122] 0 0
Mexico
State/province [122] 0 0
Chihuahua
Country [123] 0 0
Mexico
State/province [123] 0 0
Culiacan
Country [124] 0 0
Mexico
State/province [124] 0 0
Guadalajara, Jal.
Country [125] 0 0
Mexico
State/province [125] 0 0
Monterrey
Country [126] 0 0
Mexico
State/province [126] 0 0
San Luis Potosí
Country [127] 0 0
Netherlands
State/province [127] 0 0
Amersfoort
Country [128] 0 0
Netherlands
State/province [128] 0 0
Amsterdam
Country [129] 0 0
Netherlands
State/province [129] 0 0
Den Bosch
Country [130] 0 0
Netherlands
State/province [130] 0 0
Heerlen
Country [131] 0 0
Netherlands
State/province [131] 0 0
Maastricht
Country [132] 0 0
Netherlands
State/province [132] 0 0
Rotterdam
Country [133] 0 0
New Zealand
State/province [133] 0 0
Christchurch
Country [134] 0 0
New Zealand
State/province [134] 0 0
Grafton
Country [135] 0 0
New Zealand
State/province [135] 0 0
Otahuhu
Country [136] 0 0
New Zealand
State/province [136] 0 0
Takapuna Auckland 9
Country [137] 0 0
Norway
State/province [137] 0 0
Oslo
Country [138] 0 0
Norway
State/province [138] 0 0
Rud
Country [139] 0 0
Norway
State/province [139] 0 0
Trondheim
Country [140] 0 0
Poland
State/province [140] 0 0
Kielce
Country [141] 0 0
Poland
State/province [141] 0 0
Krakow
Country [142] 0 0
Poland
State/province [142] 0 0
Poznan
Country [143] 0 0
Poland
State/province [143] 0 0
Warsaw
Country [144] 0 0
Portugal
State/province [144] 0 0
Almada
Country [145] 0 0
Portugal
State/province [145] 0 0
Coimbra
Country [146] 0 0
Portugal
State/province [146] 0 0
Covilhã
Country [147] 0 0
Portugal
State/province [147] 0 0
Lisboa
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Belgorod
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Chelyabinsk
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Ekaterinburg
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Krasnodar
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Kursk
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Novosibirsk
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Omsk
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Pskov
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Rostov-na-Donu
Country [157] 0 0
Russian Federation
State/province [157] 0 0
St. Petersburg
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Tyumen
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Ufa
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Yaroslavl
Country [161] 0 0
Slovakia
State/province [161] 0 0
Banska Bystrica
Country [162] 0 0
Slovakia
State/province [162] 0 0
Lucenec
Country [163] 0 0
Slovakia
State/province [163] 0 0
Nitra
Country [164] 0 0
Slovakia
State/province [164] 0 0
Nove Zamky
Country [165] 0 0
Slovakia
State/province [165] 0 0
Zilina
Country [166] 0 0
South Africa
State/province [166] 0 0
Johannesburg
Country [167] 0 0
South Africa
State/province [167] 0 0
Pretoria
Country [168] 0 0
South Africa
State/province [168] 0 0
Randburg
Country [169] 0 0
South Africa
State/province [169] 0 0
Roodepoort
Country [170] 0 0
Spain
State/province [170] 0 0
Alicante
Country [171] 0 0
Spain
State/province [171] 0 0
Badalona (Barcelona)
Country [172] 0 0
Spain
State/province [172] 0 0
Barcelona
Country [173] 0 0
Spain
State/province [173] 0 0
Cartagena. Murcia
Country [174] 0 0
Spain
State/province [174] 0 0
Cuenca
Country [175] 0 0
Spain
State/province [175] 0 0
Madrid
Country [176] 0 0
Spain
State/province [176] 0 0
Santander
Country [177] 0 0
Spain
State/province [177] 0 0
Valencia
Country [178] 0 0
Sweden
State/province [178] 0 0
Göteborg
Country [179] 0 0
Sweden
State/province [179] 0 0
Jönköping
Country [180] 0 0
Sweden
State/province [180] 0 0
Stockholm
Country [181] 0 0
Sweden
State/province [181] 0 0
Sundsvall
Country [182] 0 0
Sweden
State/province [182] 0 0
Uppsala
Country [183] 0 0
Turkey
State/province [183] 0 0
Ankara
Country [184] 0 0
Turkey
State/province [184] 0 0
Istanbul
Country [185] 0 0
Turkey
State/province [185] 0 0
Izmir
Country [186] 0 0
Ukraine
State/province [186] 0 0
Kharkov
Country [187] 0 0
Ukraine
State/province [187] 0 0
Kiev
Country [188] 0 0
Ukraine
State/province [188] 0 0
Vinnitsa
Country [189] 0 0
Ukraine
State/province [189] 0 0
Zaporozhye
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Headington, Oxford
Country [191] 0 0
United Kingdom
State/province [191] 0 0
London
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Newcastle upon Tyne
Country [193] 0 0
United Kingdom
State/province [193] 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/NCT00329238