Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

Daniel Zimpfer, MD

Status and phase: Terminated; Phase 2

Conditions: Thrombosis; Bleeding

Treatments: Drug: Phenprocoumon; Drug: Dabigatran

Study type: Interventional

Funder types: Other

Identifiers

NCT02872649

2010-024534-38

Details and patient eligibility

About

Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation.

In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LVAD (HVAD, Heartware Inc., Framingham, MA, USA) implantation more than one month ago
• Stable renal function (clinical judgement)
• Age 18 years or older
• Ability to give informed consent

Exclusion criteria

• Severe chronic renal impairment (CL<30)
• History of significant thromboembolic events
• Significant bleeding disorder
• HIV or Hepatitis C infection
• Heparin induced thrombocytopenia
• Known hypersensitivity to Dabigatran or Phenprocoumon

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

study medication

Experimental group

Description:

Dabigatran 110mg twice daily with normal renal function (glomerular filtration rate \>80 ml/min) Dabigatran 75mg twice daily with impaired renal function (glomerular filtration rate between 80 and 30 ml/min)

Treatment:

Drug: Dabigatran

control group

Active Comparator group

Description:

Phenprocoumon dosage according to INR

Treatment:

Drug: Phenprocoumon