Dabigatran Etexilate in Patients With Mechanical Heart Valves (RE-ALIGN)

Boehringer Ingelheim

Status and phase: Terminated; Phase 2

Conditions: Heart Valve Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452347

2010-022685-27 (EudraCT Number)

1160.113

Details and patient eligibility

About

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Enrollment: 328 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

Dabigatran etexilate

Experimental group

Description:

Patient dose dependent on screening CrCl levels and TT

Treatment:

Drug: dabigatran etexilate low dose

Drug: dabigatran etexilate high dose

Drug: dabigatran etexilate intermediate dose

warfarin

Active Comparator group

Description:

warfarin doses to maintain INR levels

Treatment:

Drug: warfarin 5mg

Drug: warfarin 3mg

Drug: warfarin 1mg