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

NCT02872649 | Terminated Phase 2 DMC

• 1 other identifier: 2010-024534-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis; Bleeding

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Number of patients with necessary treatment changes

  through study completion, an average of 1 year

• Patient contentment (regular assessment with questionnaire)

  Change of Baseline Patient Contentment at 12 months

Secondary Outcomes (9)

• Treatment effects on INR (coagulation parameter)

  2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion

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

  2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion

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

  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

  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)

  2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion

Study Arms (2)

study medication

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Phenprocoumon dosage according to INR

Drug: Phenprocoumon

Interventions

Dabigatran DRUG

Also known as: Pradaxa

study medication

Phenprocoumon DRUG

Also known as: Marcoumar, Warfarin

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Zimpfer, MD: lead

Study Sites (1)

Medical Univerity Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

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

  PMID: 28500254 DERIVED

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Interventions

Dabigatran; Phenprocoumon; Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD; Associate Professor of Cardiac Surgery; Principal Investigator

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: August 19, 2016
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)