NCT02427126

Apixaban for Treatment of Embolic Stroke of Undetermined Source

Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS Randomized Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active controlled, efficacy study (phase III)

Detailed description

Based on the previous data, ATTICUS is designed as multicentre, national, parallel group, active controlled, phase III randomized (2x2 factorial), clinical trial to demonstrate the superiority of apixaban against the current standard of treatment (acetylsalicylic acid) for the longterm treatment after ESUS. ATTICUS will follow a dynamic treatment protocol implementing conversion from the acetylsalicylic acid arm to the apixaban arm in case of detection of relevant episodes of AF during the course of the study. ATTICUS is designed to test the superiority over acetylsalicylic acid to reduce new ischemic lesion detected by FLAIR/DWI MRI.

Conditions

• Embolic Stroke of Undetermined Source

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery
DRUG	Aspirin	Acetylic Salicylic Acid 100mg o.d.; 12 Months

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-08-01
• Completion: 2021-09-01
• First posted: 2015-04-27
• Last updated: 2021-10-13

Locations

16 sites across 1 country: Germany