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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with As...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004449-40

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes (39039039ACS2001) The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with or without thienopyridine therapy in Subjects with Acute Coronary Syndrome)

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Extrait

Stage 1 Dose Escalation The primary objective of Stage 1 (Dose Escalation) of this study is to evaluate the safety of rivaroxaban in subjects with recent acute coronary syndrome (ACS) (including ST-segment elevation myocardial infarction [STEMI], nonST segment elevation myocardial infarction [NSTEMI], and unstable angina [UA]) who are treated with aspirin alone or aspirin plus a thienopyridine. Stage 2: Dose Confirmation The primary objective of Stage 2 (Dose Confirmation) of this study is to evaluate the ability of rivaroxaban to reduce the combined incidence of death, myocardial infarction (MI) or repeat myocardial infarction (reMI), stroke (ischemic, hemorrhagic or unknown), or severe recurrent ischemia requiring revascularization in subjects with recent ACS (including STEMI, NSTEMI, or UA) who are treated with aspirin alone or aspirin plus a thienopyridine after medical therapy or percutaneous coronary intervention (PCI) as acute treatment.

Critère d'inclusion

  • Acute coronary syndrome

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