Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active controlled, efficacy study (phase III)
Based on the previous data, ATTICUS is designed as multicentre, national, parallel groupactive 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.
- Aspirin Drug
Other Names: Standard antiplatelet Intervention Desc: Acetylic Salicylic Acid 100mg o.d.; 12 Months ARM 1: Kind: Experimental Label: Aspirin Description: Acetylic Salicylic Acid 100mg o.d.; Study treatment: 12 months Follow-up: 30 days after last study drug intake
- Apixaban Drug
Intervention Desc: 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 ARM 1: Kind: Experimental Label: Apixaban Description: Apixaban 5mg b.i.d. Study treatment: 12 months Follow-up: 30 days after last study drug intake
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Occurrence of at least one new ischemic lesion identified by magnetic resonance imaging at 12 months when compared to the baseline MRI (FLAIR, DWI) obtained at the time of study drug initiation.||12 month||No|