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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF

NCT02256683

Atrial Fibrillation or Atrial Flutter Thrombosis of Left Atrial Appendage

TERMINATED PHASE2

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

NCT00558259

Venous Thromboembolism

COMPLETED PHASE3

Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon

NCT02591225

Atrial Fibrillation Left Atrial Thrombosis

UNKNOWN PHASE4

Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.

NCT02596555

Pulmonary Embolism

TERMINATED PHASE4

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

NCT00291330

Thromboembolism

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombosis Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

study medication

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)

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

control group

Phenprocoumon dosage according to INR

Group Type ACTIVE_COMPARATOR

Phenprocoumon

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dabigatran

Intervention Type DRUG

Phenprocoumon

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pradaxa Marcoumar Warfarin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No