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

August 15, 2016 updated by: Daniel Zimpfer, MD

Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical Univerity Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pradaxa
Active Comparator: control group
Phenprocoumon dosage according to INR
Drug: Phenprocoumon
Other Names:
  • Warfarin
  • Marcoumar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year
Number of patients with necessary treatment changes
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
Time Frame: Change of Baseline Patient Contentment at 12 months
Change of Baseline Patient Contentment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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
2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Zimpfer, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 2, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-024534-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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