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safety reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| control group | Active Comparator | Phenprocoumon dosage according to INR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug |
|
| |
| Phenprocoumon |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment effects on TT (thrombin clotting time; coagulation parameter) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univerity Vienna | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28500254 | Derived | 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. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D010644 | Phenprocoumon |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Drug |
|
|
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) | 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 | 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) | 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) | 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 | 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 | 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 | 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |