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See Latest ArticlesRivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): A randomised, double-blind, phase II trial
The Lancet - Early Online Publication, 06/19/09
Mega JL et al. – Use of an oral factor Xa inhibitor in pts stabilized after an acute coronary syndrome increases bleeding in a dose-dependent manner and may reduce major ischemic outcomes. These findings are the basis for a phase III study of low-dose rivaroxaban as adjunctive therapy in these pts.
Methods- Study of safety and efficacy of rivaroxaban
- Evaluation of most favorable dose and dosing regimen
- Double-blind, dose-escalation, phase II trial, at 297 sites in 27 countries
- Stratification of 3491 pts stabilized after acute coronary syndrome based on investigator decision to aspirin only (761 pts: stratum 1) or aspirin + thienopyridine (2730 pts: stratum 2
- Randomization within each strata and dose tier by block randomization at 1:1:1 to either placebo or rivaroxaban (5-20 mg) once daily or twice daily (same total daily dose)
- Primary safety endpoint: clinically significant bleeding (TIMI major, TIMI minor, or requiring medical attention)
- Primary efficacy endpoint: death, myocardial infarction, stroke, or severe recurrent ischemia requiring revascularization during 6 mo
- Safety analyses of all pts who received ≥1 dose of study drug
- Study drug never received for 3 stratum 1 pts and 26 stratum 2
- Risk of clinically significant bleeding with rivaroxaban vs placebo increased in dose-dependent manner
- Rates of primary efficacy endpoint: 5.6% (126/2331) for rivaroxaban vs 7.0% (79/1160) for placebo
- Rivaroxaban reduced main secondary efficacy endpoint of death, myocardial infarction, or stroke vs placebo (87/2331 [3.9%] vs 62/1160 [5.5%]
- Most common adverse event in both groups: chest pain (248/2309 [10.7%] vs 118/1153 [10.2%])
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