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news.Bristol-Myers Squibb Company and Pfizer has announced encouraging results of a Phase II dose-ranging study involving the investigational compound apixaban in patients with acute coronary syndrome.
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The study compared the current standard of care for acute coronary syndrome (ACS), including aspirin and clopidogrel, with apixaban on top of the standard of care.
The six-month Appraise-1 study was not powered to demonstrate significance on the composite efficacy endpoint of cardiovascular death, non-fatal heart attack, severe recurrent ischemia and non-hemorrhagic stroke. However, there was a non-significant relative risk reduction compared to placebo (n=611) of 27% for 2.5mg twice daily (n=317) and 39% for 10mg once daily (n= 318) doses.
The incidence of the primary endpoint of this safety study, major bleeding plus clinically relevant non-major bleeding, was 5.7% for apixaban patients who took the 2.5mg twice daily dose (n=315), 7.9% for patients who took the 10mg once daily dose (n=315), and 3% for patients who took placebo (n=599). The bleeding scale used in the Appraise-1 trial was the comprehensive International Society of Thrombosis and Haemostasis (ISTH) standard.
The incidence of major ISTH bleeding was 0.8% with placebo (n=599) versus 1.6 and 1.9% with the 2.5 mg twice daily (n=315) and 10mg once daily (n=315) doses, respectively.
Results for major bleeding measured using the more commonly used thrombolysis in myocardial infarction scale, in a post-hoc assessment, were 0.3% (n=599) for placebo, 0.0% (n=315) for the 2.5mg twice daily apixaban dose and 1% (n= 315) for the 10mg once daily apixaban dose.
Two additional arms of the study that examined higher doses, 10 mg twice daily and 20 mg once daily, were stopped early due to increased total bleeding.