drugset / Trial / NCT02872649

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

NCT02872649

Phase 2 Terminated 16 enrolled Daniel Zimpfer, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-01
Primary completion
2015-06
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 75 mg Oral
Subject Dabigatran Unknown 110 mg Oral
Comparator Phenprocoumon Small molecule