Clinical trial NCT00291330: Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 2564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 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. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.


Eligibility 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

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

Primary outcomes:
measure: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
timeFrame: 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 outcomes:
measure: Number of Participants With Recurrent Symptomatic VTE and All Deaths
timeFrame: 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.
measure: Number of Participants With Recurrent Symptomatic DVT
timeFrame: 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.
measure: Number of Participants With Recurrent Symptomatic Non-fatal PE
timeFrame: 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.
measure: Number of Participants Who Died Due to VTE
timeFrame: 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.
measure: Number of Participants Who Died (Any Cause)
timeFrame: 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.
measure: Number of Participants With Bleeding Events
timeFrame: 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)
measure: Number of Participants With Acute Coronary Syndrome (ACS)
timeFrame: From first intake of study drug to end of study conduct
measure: Laboratory Analyses
timeFrame: 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)
Other outcomes:
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country: Norway
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country: Norway
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country: Norway
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Rostov-na-Donu
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
facility: 1160.53.07014 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.53.07005 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.53.07006 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1160.53.42107 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1160.53.42106 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1160.53.42102 Boehringer Ingelheim Investigational Site
city: Nove Zamky
country: Slovakia
facility: 1160.53.42103 Boehringer Ingelheim Investigational Site
city: Zilina
country: Slovakia
facility: 1160.53.42104 Boehringer Ingelheim Investigational Site
city: Centurion
country: South Africa
facility: 1160.53.27007 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.53.27001 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.53.27002 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.53.27004 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.53.27006 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1160.53.27009 Suite 404, Medical Centre
city: Randburg
country: South Africa
facility: 1160.53.27003 Boehringer Ingelheim Investigational Site
city: Richards Bay
country: South Africa
facility: 1160.53.27008 Suite M5, Second Floor
city: Roodepoort
country: South Africa
facility: 1160.53.27005 Boehringer Ingelheim Investigational Site
city: Badalona (Barcelona)
country: Spain
facility: 1160.53.34012 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.53.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.53.34002 Boehringer Ingelheim Investigational Site
city: Cartagena. Murcia
country: Spain
facility: 1160.53.34007 Boehringer Ingelheim Investigational Site
city: Cuenca
country: Spain
facility: 1160.53.34003 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.53.34009 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.53.34010 Boehringer Ingelheim Investigational Site
city: Santander
country: Spain
facility: 1160.53.34004 Boehringer Ingelheim Investigational Site
city: Torrelavega.Santander
country: Spain
facility: 1160.53.34005 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.53.34011 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.53.46002 Boehringer Ingelheim Investigational Site
city: Jönköping
country: Sweden
facility: 1160.53.46006 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.53.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.53.46007 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.53.46008 Boehringer Ingelheim Investigational Site
city: Sundsvall
country: Sweden
facility: 1160.53.46005 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1160.53.46003 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.53.90003 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.53.90004 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.53.90005 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.53.90001 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.53.90002 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.53.90007 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 1160.53.90006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1160.53.38006 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1160.53.38005 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 1160.53.38003 Boehringer Ingelheim Investigational Site
city: Aberdeen
country: United Kingdom
facility: 1160.53.44008 Boehringer Ingelheim Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: 1160.53.44005 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.53.44004 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.53.44009 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.53.44011 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1160.53.44006 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 1160.53.44012 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
citation: 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.
citation: Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.