Secondary Prevention of Venous Thrombo Embolism.

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (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 six months for confirmed acute symptomatic Venous Thrombo-embolism.

Official Title

A Randomised, Multicenter, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Dabigatran Etexilate, 150 mg b.i.d Administered Orally (Capsules) for 18 Months, Compared to Warfarin Tablets p.r.n. (Target INR) for the Secondary Prevention of Venous Thromboembolism.

Conditions

Thromboembolism

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Further Details

Primary Outcome Measures:

• Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. VTE is defined as the composite incidence of Deep Venous Thromboembolism and Pulmonary Embolism.

Secondary Outcome Measures:

• Composite of recurrent symptomatic VTE and all deaths
• Symptomatic DVT
• Symptomatic PE
• Deaths related to VTE
• All deaths

Study Start

May 2006; Expected completion: May 2010

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both
• Inclusion Criteria: Acute symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) 3-6 months prior to screening, which has been documented by objective testing
• Exclusion Criteria: Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-6 months of treatment for the prior VTE; Patients who in the investigators judgement are perceived as having an excessive risk of bleeding; Elevated AST or ALT > 2x ULN; Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

Total Enrolment

2004

Contact Details

Boehringer Ingelheim Study Coordinator: clintriage@rdg.boehringer-ingelheim.com

• Princess Alexandra Hospital, Woolloongabba, Queensland, Australia; Recruiting
• Boehringer Ingelheim Investigational Site, Bedford Park, South Australia, Australia; Recruiting
• Boehringer Ingelheim Investigational Site, Clayton, Victoria, Australia; Recruiting
• Boehringer Ingelheim Investigational Site, Box Hill, Victoria, Australia; Recruiting
• Boehringer Ingelheim Investigational Site, Windsor, Victoria, Australia; Recruiting
• Boehringer Ingelheim Investigational Site, Perth, Western Australia, Australia; Recruiting