Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes

Phase 2 Completed 1276 enrolled Astellas Pharma Europe B.V.

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.

Timeline

Start: 2009-09
Primary completion: 2011-02
Completion: 2011-03

Outcome

Missed primary endpoint

paper Bleeding rates were numerically higher in all darexaban arms vs. placebo (pooled HR: 2.275; 95% CI: 1.13-4.60, P = 0.022). PMID 21878434 ↗

Publications

Steg PG, Mehta SR, Jukema JW, Lip GY, Gibson CM, Kovar F, Kala P, Garcia-Hernandez A, Renfurm RW, Granger CB; RUBY-1 Investigators. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome. Eur Heart J. 2011 Oct;32(20):2541-54. doi: 10.1093/eurheartj/ehr334. Epub 2011 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	darexaban	Small molecule	5 mg	Oral
Subject	darexaban	Small molecule	10 mg	Oral
Subject	darexaban	Small molecule	15 mg	Oral
Subject	darexaban	Small molecule	30 mg	Oral
Subject	darexaban	Small molecule	60 mg	Oral