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

Primary Purpose

Thrombosis, Bleeding

Status

Terminated

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Dabigatran

Phenprocoumon

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Univerity Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study medication

control group

Arm Description

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)

Phenprocoumon dosage according to INR

Outcomes

Primary Outcome Measures

Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications

Number of major and minor bleeding events (INTERMACS definition)

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

Number of patients with necessary treatment changes

Patient contentment (regular assessment with questionnaire)

Secondary Outcome Measures

Treatment effects on INR (coagulation parameter)

measured via a blood test

Treatment effects on TT (thrombin clotting time; coagulation parameter)

measured via a blood test

Treatment effects on Glomerular Filtration Rate (GFR; renal parameter)

measured via a blood test

Treatment effects on Pump Flow (pump parameter), measured in L/min

Treatment effects on PTT (activated partial thromboplastin time; coagulation parameter)

measured via a blood test

Treatment effects on Creatinine (renal parameter)

measured via blood test

Treatment effects on Pump Speed (pump parameter), measured in RPM

Treatment effects on Pump Pulsatility (pump parameter), measured in L/min

Treatment effects on Pump Power (pump parameter), measured in W

Full Information

NCT ID

NCT02872649

First Posted

April 2, 2016

Last Updated

August 15, 2016

Sponsor

Daniel Zimpfer, MD

1. Study Identification

Unique Protocol Identification Number

NCT02872649

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

safety reasons

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniel Zimpfer, MD

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombosis, Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study medication

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

Active Comparator

Arm Description

Phenprocoumon dosage according to INR

Intervention Type

Drug

Intervention Name(s)

Dabigatran

Other Intervention Name(s)

Pradaxa

Intervention Type

Drug

Intervention Name(s)

Phenprocoumon

Other Intervention Name(s)

Marcoumar, Warfarin

Primary Outcome Measure Information:

Title

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

Title

Number of major and minor bleeding events (INTERMACS definition)

Description

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

Time Frame

through study completion, an average of 1 year

Title

Number of patients with necessary treatment changes

Time Frame

through study completion, an average of 1 year

Title

Patient contentment (regular assessment with questionnaire)

Time Frame

Change of Baseline Patient Contentment at 12 months

Secondary Outcome Measure Information:

Title

Treatment effects on INR (coagulation parameter)

Description

measured via a blood test

Time Frame