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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
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Uppsala
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Turkey
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Vinnitsa
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Ukraine
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London
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Newcastle upon Tyne
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Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
Trial website
https://clinicaltrials.gov/study/NCT00329238
Trial related presentations / publications
Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00329238