drugset / Trial / NCT02872649
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran | Unknown | 75 mg | Oral |
| Subject | Dabigatran | Unknown | 110 mg | Oral |
| Comparator | Phenprocoumon | Small molecule | — | — |