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

PHASE2TerminatedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Atrial Fibrillation or Atrial FlutterThrombosis of Left Atrial Appendage
Interventions
DRUG

Dabigatran etexilate

After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.

DRUG

Phenprocoumon

After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.

Trial Locations (14)

10117

Charité Universitätsmedizin Berlin, Berlin

76133

Städtisches Klinikum Karlsruhe, Karlsruhe

96450

Klinikum Coburg GmbH, Coburg

D-79189

University Heart Center; Department of Cardiology and Angiology II, Bad Krozingen

D-10967

Vivantes Clinical Center Am Urban; General Internal Medicine and conservative intensive care, Berlin

D-50937

University Heart Center; Department of Cardiology, Cologne

D-01307

University Heart Center; Department of Invasive Electrophysiology, Dresden

D-20246

University Heart Center; Department of Cardiology, Electrophysiology, Hamburg

D-30625

Hannover Medical School; Department of Cardiology and Angiology, Hanover

04103

Universitätsmedizin Leipzig, Leipzig

D-55131

University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology, Mainz

D-48149

University Medical Center, Münster

D-33098

St. Vincenz-Hospital GmbH, Paderborn

D-18057

Rostock University Hospital; Rhythmology and Clinical Electrophysiology, Rostock

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

collaborator

Atrial Fibrillation Network

OTHER

lead

Johannes Gutenberg University Mainz

OTHER