ThrombosisPhase 2NCT02872649
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
A Phase 2 study testing Dabigatran and Phenprocoumon in people with Thrombosis and Bleeding, run by Daniel Zimpfer, MD at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Bleeding
- What is being tested?
- Dabigatran and Phenprocoumon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Thrombosis, Bleeding
- Being tested
- Dabigatran, Phenprocoumon
- Medical subject headings
- Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Also called Pradaxa
PhenprocoumonDrug
Also called Marcoumar, Warfarin
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Dabigatran |
| control group | Active comparator | Phenprocoumon dosage according to INR Receives: Drug: Phenprocoumon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
Measured: 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
Measured: through study completion, an average of 1 year
Number of patients with necessary treatment changes
Measured: through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
Measured: Change of Baseline Patient Contentment at 12 months
Secondary outcomes (9)
Treatment effects on INR (coagulation parameter)
measured via a blood test
Measured: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Treatment effects on TT (thrombin clotting time; coagulation parameter)
measured via a blood test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionFeb 2016
Why it stopped: safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Zimpfer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Zimpfer, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872649
- Sponsor's protocol ID
- 2010-024534-38
- Status last verified
- Aug 2016
- First submitted
- 2 Apr 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28500254
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT02872649
- Acronym / sponsor ID
- 2010-024534-38
- Conditions
- Thrombosis, Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety reasons
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Daniel Zimpfer, MDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study medication | Experimental | Drug: DabigatranDabigatran 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 | Drug: PhenprocoumonPhenprocoumon dosage according to INR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Severe chronic renal impairment (CL<30)
- History of significant thromboembolic events
- Significant bleeding disorder
- HIV or Hepatitis C infection
- Heparin induced thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabigatranAlso: Pradaxa | Drug | study medication |
| PhenprocoumonAlso: Marcoumar, Warfarin | Drug | control group |
Primary outcome
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
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
Number of patients with necessary treatment changes
Time frame: through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
Time frame: Change of Baseline Patient Contentment at 12 months
9 secondary outcomes
Treatment effects on INR (coagulation parameter)
Time frame: 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
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
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
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
Treatment effects on Creatinine (renal parameter)
Time frame: 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
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
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
Results and safety
The study was stopped early (reason given: safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 28500254Andreas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dabigatran and Phenprocoumon in people with Thrombosis and Bleeding, run by Daniel Zimpfer, MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: safety reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.