TerminatedPhase 2

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

Stopped: safety reasons

Austria16 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: through study completion, an average of 1 year

Number of major and minor bleeding events (INTERMACS definition)

Timeframe: through study completion, an average of 1 year

Number of patients with necessary treatment changes

Timeframe: through study completion, an average of 1 year

Patient contentment (regular assessment with questionnaire)

Timeframe: Change of Baseline Patient Contentment at 12 months

Trial details

NCT IDNCT02872649

SponsorDaniel Zimpfer, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Thrombosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: through study completion, an average of 1 year

Number of major and minor bleeding events (INTERMACS definition)

Timeframe: through study completion, an average of 1 year

Number of patients with necessary treatment changes

Timeframe: through study completion, an average of 1 year

Patient contentment (regular assessment with questionnaire)

Timeframe: Change of Baseline Patient Contentment at 12 months