Comparison of the designs of the trials evaluating NOACs for extended VTE treatment
| . | Dabigatran . | Rivaroxaban . | Apixaban . | |
|---|---|---|---|---|
| Trial | RE-SONATE | RE-MEDY | EINSTEIN-Ext | AMPLIFY-Ext |
| Comparator | Placebo | Warfarin | Placebo | Placebo |
| Design | Double-blind | Double-blind | Double-blind | Double-blind |
| Number of patients | 1343 | 2856 | 1197 | 2486 |
| Noninferiority margin | — | 2.85 | — | — |
| Duration of prior anticoagulation treatment (mo) | 6-18 | 3-12 | 6-12 | 3-12 |
| Treatment protocol | 150 mg BID | 150 mg BID | 20 mg OD | 2.5 or 5 mg BID |
| Duration (mo) | 6 | 6-36 | 6-12 | 12 |
| . | Dabigatran . | Rivaroxaban . | Apixaban . | |
|---|---|---|---|---|
| Trial | RE-SONATE | RE-MEDY | EINSTEIN-Ext | AMPLIFY-Ext |
| Comparator | Placebo | Warfarin | Placebo | Placebo |
| Design | Double-blind | Double-blind | Double-blind | Double-blind |
| Number of patients | 1343 | 2856 | 1197 | 2486 |
| Noninferiority margin | — | 2.85 | — | — |
| Duration of prior anticoagulation treatment (mo) | 6-18 | 3-12 | 6-12 | 3-12 |
| Treatment protocol | 150 mg BID | 150 mg BID | 20 mg OD | 2.5 or 5 mg BID |
| Duration (mo) | 6 | 6-36 | 6-12 | 12 |
BID, twice daily; Ext, extension; OD, once daily.