Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Thromboembolism

Treatments: Drug: Warfarin; Drug: Dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680186

2007-002631-86 (EudraCT Number)

1160.46

Details and patient eligibility

About

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Enrollment: 2,589 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
• Male or female, being 18 years of age or older
• Written informed consent for study participation

Exclusion criteria

• Persistent symptoms of VTE
• PE requiring urgent intervention
• Use of vena cava filter
• Contraindications to anticoagulant therapy
• Allergy to study medications
• Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
• Severe renal impairment
• Patients considered unsuitable for inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,589 participants in 2 patient groups

Dabigatran etexilate (150mg bid)

Experimental group

Description:

Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily

Treatment:

Drug: Dabigatran etexilate

Warfarin (INR 2.0-3.0)

Active Comparator group

Description:

Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

Treatment:

Drug: Warfarin