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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02872649
• Other study ID #: 2010-024534-38
• Status: Terminated
• Phase: Phase 2
• First received: April 2, 2016
• Last updated: August 15, 2016
• Start date: January 2013
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Thrombosis

Intervention

Drug:
• Dabigatran

• Phenprocoumon

Locations

Country	Name	City	State
Austria	Medical Univerity Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Zimpfer, MD

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications		through study completion, an average of 1 year	Yes
Primary	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	through study completion, an average of 1 year	Yes
Primary	Number of patients with necessary treatment changes		through study completion, an average of 1 year	No
Primary	Patient contentment (regular assessment with questionnaire)		Change of Baseline Patient Contentment at 12 months	No
Secondary	Treatment effects on INR (coagulation parameter)	measured via a blood test	2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on TT (thrombin clotting time; coagulation parameter)	measured via a blood test	2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Glomerular Filtration Rate (GFR; renal parameter)	measured via a blood test	2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Pump Flow (pump parameter), measured in L/min		2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on PTT (activated partial thromboplastin time; coagulation parameter)	measured via a blood test	2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Creatinine (renal parameter)	measured via blood test	2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Pump Speed (pump parameter), measured in RPM		2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Pump Pulsatility (pump parameter), measured in L/min		2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No
Secondary	Treatment effects on Pump Power (pump parameter), measured in W		2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion	No