Apixaban for Prevention of Acute Ischaemic Events - 2

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban in Subjects with a Recent Acute Coronary Syndrome

• IRAS ID

  16522

• Sponsor organisation

  Bristol−Myers Squibb Company Research & Development

• Eudract number

  2008-008298-77

• ISRCTN Number

  N/A

• Research summary

  The purpose of this study (APPRAISE-2) is to find out if the experimental research drug, apixaban, is safe and can prevent further cardiovascular events, such as another heart attack, unstable angina, or stroke, when given in addition to standard treatment to participants who have recently experienced unstable angina or a heart attack, as these participants are at risk of developing further cardiovascular events. Apixaban is an experimental drug which means that it is one that's being tested and has not yet been approved for sale by the regulatory authorities. Drugs which act at different stages of the blood clotting process are an important part of treatment in patients with ACS. Standard available treatments only act on specific stages of the clotting process. The study drug, Apixaban, is one of a new class of drugs that blocks the action of factor Xa (FXa), which plays a key role in the blood clotting process. Apixaban may therefore have the potential to replace or complement currently used anticoagulant and antiplatelet drug in ACSParticipants will be randomised (given treatment at random, like the flip of a coin) to either apixaban or placebo(an inactive 'dummy' drug)in a 1:1 ratio. Participants will therefore have an equal chance of receiving either apixaban or placebo. Randomization will be split into 2 groups; those taking single antiplatelet therapy and those taking dual antiplatelet therapy. Participants will receive either apixaban 5 mg or placebo twice daily, or apixaban 2.5 mg or placebo twice daily (the dose will depend on how the participant's kidneys are working at randomisation). Approximately 1000 centres in approximately 40 countries worldwide will take part in the study. Total enrolment will be approximately 10,800 randomised participants. The study is expected to start in the UK in May 2009 and last for 28 months.* The study progress will be monitored closely by several independent committees.The study is funded by Bristol Myers Squibb. * Study recruitment has now ended and all patients have discontinued study treatment

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/46

• Date of REC Opinion

  19 May 2009

• REC opinion

  Further Information Favourable Opinion