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RE-LATED_AF: Dabigatran vs Phenprocoumon for LAA Thrombus Resolution

NCT02256683Phase 2

Key facts

Status: Terminated
Start: Jul 2014
Primary completion: May 2018
Countries: 1
Sponsor: Johannes Gutenberg University Mainz
Modality: Small Molecules

Drugs: dabigatran
Conditions: left atrial appendage thrombus

Overview

Phase 2, randomised, open-label trial of dabigatran in left atrial appendage thrombus (2 arms), sponsored by Johannes Gutenberg University Mainz. Primary endpoint: Time to complete left atrial appendage (LAA) thrombus resolution. Started Jul 2014; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Dabigatran
Dabigatran etexilate 150 mg bid
Phenprocoumon
Phenprocoumon (INR 2-3)

Endpoints

Primary

Time to complete left atrial appendage (LAA) thrombus resolution3-6 weeks

Secondary

Complete LAA thrombus resolution until week 66 weeks
Change in LAA thrombus volume under treatment3-6 weeks
Occurrence of any adverse event3-6 weeks
Occurrence of major bleedings3-6 weeks
Occurrence of strokes (all-type, haemorrhagic, ischemic)3-6 weeks
Occurrence of transient ischaemic attacks (TIAs)3-6 weeks
Occurrence of cardiovascular events requiring hospitalization3-6 weeks
Occurrence of other thromboembolic events3-6 weeks

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