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At least as efficacious as current standard therapyAt least as safe as current standard therapyAvailable for oral administrationRequire no monitoringNo relevant interactions with food and common drugsCost-effective... in order to aid treatment compliance and avoid the serious consequences of thrombosis and bleeding.
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1. Stroke prevention in patients with atrial fibrillation – findings from the Phase II PETRO trial and ongoing Phase III RE-LY trial Lars Wallentin
University Hospital, Uppsala, Sweden
3. Key features of new oral anticoagulants
4. PETRO: study design
5. PETRO and PETRO-Ex: accumulated results
6. Bear in mind only 408 patients at outset of dabigatran curve versus >6000 for ximelagatranBear in mind only 408 patients at outset of dabigatran curve versus >6000 for ximelagatran
8. Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, Parallel-Group, Non-Inferiority Trial (RE-LY Study)
The RE-LY trial compares warfarin to two blinded doses of RENDIX™ (dabigatran etexilate)
The trial has a randomization of 2:1 - 10,000 patients on RENDIX™ and 5,000 on warfarin
Treatment will be open label with regards to warfarin however the two doses of RENDIX™ will be blinded
Treatment duration will be up to three years with patients followed-up until the trial is closed (a follow-up range of 1-3 years)
Patients are seen every 3-4 months
The mean treatment period is 20-24 months
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, Parallel-Group, Non-Inferiority Trial (RE-LY Study)
The RE-LY trial compares warfarin to two blinded doses of RENDIX™ (dabigatran etexilate)
The trial has a randomization of 2:1 - 10,000 patients on RENDIX™ and 5,000 on warfarin
Treatment will be open label with regards to warfarin however the two doses of RENDIX™ will be blinded
Treatment duration will be up to three years with patients followed-up until the trial is closed (a follow-up range of 1-3 years)
Patients are seen every 3-4 months
The mean treatment period is 20-24 months
9. Conclusions on new anticoagulants in arterial thromboembolism
10. RE-DEEM study – Dabigatran dose guiding in ACS