Follow on Study From RE-ALIGN

Boehringer Ingelheim

Status and phase: Terminated; Phase 2

Conditions: Thromboembolism; Heart Valve Prosthesis

Treatments: Drug: dabigatran etexilate high dose; Drug: warfarin 3mg; Drug: warfarin 5mg; Drug: warfarin 1mg; Drug: dabigatran etexilate low dose; Drug: dabigatran etexilate intermediate dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505881

1160.138

2011-002285-21 (EudraCT Number)

Details and patient eligibility

About

To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Enrollment: 158 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Dabigatran etexilate

Experimental group

Description:

Patient dose determined by dose allocated in 1160.113 and CrCl levels

Treatment:

Drug: dabigatran etexilate high dose

Drug: dabigatran etexilate intermediate dose

Drug: dabigatran etexilate low dose

warfarin

Active Comparator group

Description:

warfarin doses to maintain INR levels

Treatment:

Drug: warfarin 3mg

Drug: warfarin 5mg

Drug: warfarin 1mg