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

• ClinicalTrials.gov Identifier: NCT02872649
• Recruitment Status: Terminated
• First Posted: August 19, 2016
• Last Update Posted: August 19, 2016
• Sponsor: Daniel Zimpfer, MD
• Information provided by (Responsible Party): Daniel Zimpfer, MD, Medical University of Vienna

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thrombosis; Bleeding	Drug: Dabigatran; Drug: Phenprocoumon	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device
• Study Start Date: January 2013
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: study medication; 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)	Drug: Dabigatran; Other Name: Pradaxa
Active Comparator: control group; Phenprocoumon dosage according to INR	Drug: Phenprocoumon; Other Names: Marcoumar; Warfarin

Outcome Measures

Primary Outcome Measures :

1. Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications [ Time Frame: through study completion, an average of 1 year ]
2. Number of major and minor bleeding events (INTERMACS definition) [ Time Frame: through study completion, an average of 1 year ]
   an episode of internal or external bleeding that results in death, the need for re-operation or hospitalization; or necessitates transfusion of red blood cells
3. Number of patients with necessary treatment changes [ Time Frame: through study completion, an average of 1 year ]
4. Patient contentment (regular assessment with questionnaire) [ Time Frame: Change of Baseline Patient Contentment at 12 months ]

Secondary Outcome Measures :

1. Treatment effects on INR (coagulation parameter) [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
   measured via a blood test
2. Treatment effects on TT (thrombin clotting time; coagulation parameter) [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
   measured via a blood test
3. Treatment effects on Glomerular Filtration Rate (GFR; renal parameter) [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
   measured via a blood test
4. Treatment effects on Pump Flow (pump parameter), measured in L/min [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
5. Treatment effects on PTT (activated partial thromboplastin time; coagulation parameter) [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
   measured via a blood test
6. Treatment effects on Creatinine (renal parameter) [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
   measured via blood test
7. Treatment effects on Pump Speed (pump parameter), measured in RPM [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
8. Treatment effects on Pump Pulsatility (pump parameter), measured in L/min [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]
9. Treatment effects on Pump Power (pump parameter), measured in W [ Time Frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Medical Univerity Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Daniel Zimpfer, MD

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andreas M, Moayedifar R, Wieselthaler G, Wolzt M, Riebandt J, Haberl T, Angleitner P, Schlöglhofer 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). pii: e003709. doi: 10.1161/CIRCHEARTFAILURE.116.003709.

• Responsible Party: Daniel Zimpfer, MD, MD; Associate Professor of Cardiac Surgery; Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02872649
• Other Study ID Numbers: 2010-024534-38
• First Posted: August 19, 2016
• Last Update Posted: August 19, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Warfarin; Dabigatran; Phenprocoumon; Anticoagulants; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action