New medication for the prophylaxis of thrombosis in patients with mechanical heart support

Pilot-Trial: Dabigatran as an alternative anticoagulant in patients with left ventricular assist device

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024534-38-AT

Enrollment

Registered

2011-06-06

Start date

2011-07-19

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with implanted left ventricular assist device MedDRA version: 13.1 Level: LLT Classification code 10052374 Term: Left ventricular assist device insertion System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: PRADAXA 110 mg - Hartkapseln Product Name: PRADAXA 110 mg - Hartkapseln Pharmaceutical Form: Tablet Trade Name: PRADAXA 75 mg - Hartkapseln Product Name: EU/1/08/442/001-004 Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Planned or recent LVAD (HeartWare, HeartWare International Inc., Framingham, MA, USA) implantation - Age 18 years or older - Ability to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Severe chronic renal impairment (creatinine clearence (CLCR) <30ml/min) - History of significant major thromboembolic events - Significant bleeding disorder - HIV or Hepatitis C infection - Heparin induced thrombocytopenia - Known hypersensitivity to Dabigatran, Dalteparin or Phenprocoumon

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess safety of Dabigatran administration in LVAD (HeartWare) patients ;Secondary Objective: 2) To estimate sample size for a multi-center clinical trial 3) To evaluate patient contentment in this patient cohort ;Primary end point(s): - Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications - Number of major and minor bleeding events (TIMI bleeding classification) - Patient contentment (regular assessment with a questionnaire) - Number of patients with necessary treatment changes ;Timepoint(s) of evaluation of this end point: every visit during the study	—

Measure

Time frame

Main Objective: To assess safety of Dabigatran administration in LVAD (HeartWare) patients ;Secondary Objective: 2) To estimate sample size for a multi-center clinical trial 3) To evaluate patient contentment in this patient cohort ;Primary end point(s): - Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications - Number of major and minor bleeding events (TIMI bleeding classification) - Patient contentment (regular assessment with a questionnaire) - Number of patients with necessary treatment changes ;Timepoint(s) of evaluation of this end point: every visit during the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Increase of liver enzymes > 3 times upper limit - Treatment effects on coagulation parameters ;Timepoint(s) of evaluation of this end point: every routine blood draw during the study	—

Countries

Austria

Contacts

Public ContactAbteilung für Herzchirurgie

Medizinische Universität Wien

martin.andreas@meduniwien.ac.at+431404006969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 10, 2026