Clinical trial NCT02872649: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
Official title: Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thrombosis
Bleeding
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
timeFrame: through study completion, an average of 1 year
measure: Number of major and minor bleeding events (INTERMACS definition)
timeFrame: through study completion, an average of 1 year
measure: Number of patients with necessary treatment changes
timeFrame: through study completion, an average of 1 year
measure: Patient contentment (regular assessment with questionnaire)
timeFrame: Change of Baseline Patient Contentment at 12 months
Secondary outcomes:
measure: Treatment effects on INR (coagulation parameter)
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on TT (thrombin clotting time; coagulation parameter)
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Glomerular Filtration Rate (GFR; renal parameter)
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Pump Flow (pump parameter), measured in L/min
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on PTT (activated partial thromboplastin time; coagulation parameter)
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Creatinine (renal parameter)
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Pump Speed (pump parameter), measured in RPM
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Pump Pulsatility (pump parameter), measured in L/min
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
measure: Treatment effects on Pump Power (pump parameter), measured in W
timeFrame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical Univerity Vienna
Study officials:
References:
citation: Andreas M, Moayedifar R, Wieselthaler G, Wolzt M, Riebandt J, Haberl T, Angleitner P, Schloglhofer T, Wiedemann D, Schima H, Laufer G, Zimpfer D. Increased Thromboembolic Events With Dabigatran Compared With Vitamin K Antagonism in Left Ventricular Assist Device Patients: A Randomized Controlled Pilot Trial. Circ Heart Fail. 2017 May;10(5):e003709. doi: 10.1161/CIRCHEARTFAILURE.116.003709.