Subscribe: Latest / All - Designed by Dr James P Howard (Google+)
RE-LY TRIAL |
|
|---|---|
| Problem | Atrial Fibrillation |
| Format | Multicenter, parallel-group, randomized controlled trial |
| Treatment | Dabigatran |
| Control | Warfarin |
| Population | 18,113 patients |
| Inclusion criteria | AF Age >75 years or 65-74 years with T2DM, HTN, or CAD One of: -Previous stroke or TIA -LVEF <40% -NYHA class II-IV within 6 months |
| Exclusion criteria | Severe valvular disease Stroke within 14 days Severe stroke within 6 months of screening Condition conveying an increased risk of hemorrhage Creatinine clearance <30 ml/min Active liver disease Pregnancy |
| Follow-up | Median 2.0 years |
| Primary endpoint | Stroke or systemic embolism Primary safety endpoint of major bleeding |
| Secondary endpoint(s) | Stroke PE Hospitalization Vascular death All-cause mortality Major hemorrhage |
| Details | . |
| Brief summary: | 150mg Dabi less stroke than warfarin, similar bleeding. |
| PAPER: Dabigatran versus Warfarin in Patients with Atrial Fibrillation | |
|---|---|
| Date | 17 Sep 2009 |
| Journal | N Engl J Med. 2009 Sep 17;361(12):1139-51 |
| Information | 150mg Dabigatran -significantly lower rate of stroke & embolism -similar rate of major bleeding 110mg Dabigatran -similar rate of stroke & embolism -lower rate of major bleeding Both doses -significantly reduced risk of intracranial haemorrhage -increased risk of GI bleeding -dyspepsia most common side-effect |