Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Thromboembolism

Treatments: Drug: Warfarin; Drug: Dabigatran

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329238

2005-002536-94 (EudraCT Number)

1160.47

Details and patient eligibility

About

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.

Enrollment: 2,867 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,867 participants in 2 patient groups

Dabigatran

Experimental group

Description:

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

Treatment:

Drug: Dabigatran

Warfarin (INR of 2.0-3.0)

Active Comparator group

Description:

Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Treatment:

Drug: Warfarin