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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872649


Locations
Austria
Medical Univerity Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Daniel Zimpfer, MD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Zimpfer, MD, MD; Associate Professor of Cardiac Surgery; Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02872649     History of Changes
Other Study ID Numbers: 2010-024534-38
First Posted: August 19, 2016    Key Record Dates
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
Anticoagulants
Dabigatran
Phenprocoumon
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action