Study to evaluate the efficacy & safety of rivaroxaban in ACS (V 1.0)

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome. The ATLAS ACS 2 TIMI 51 Trial ( The second trial of Anti-Xa Therapy to Lower cardiovascular events in addition to standard therapy in Subjects with Acute Coronary Syndrome)

• IRAS ID

  11288

• Sponsor organisation

  Johnson & Johnson Pharmaceutical Research & Development, represented by Janssen-Cliag International NV

• Eudract number

  2008-002708-25

• ISRCTN Number

  n/a

• Research summary

  Acute Coronary Syndrome (ACS), also known as heart attack or unstable angina, occurs when a blockage, made up of cholesterol, in one of the heart blood vessels develops a tear. This trauma causes a blood clot to form around the tear which blocks the supply of blood and oxygen to the heart muscle. This type of blood clot can cause a heart attack or stroke. The current "standard care" treatment for patients with ACS is aspirin and, where appropriate, a thienopyridine (such as clopidogrel), both of which are anticoagulants (blood thinners).The aim of this study is to determine whether Rivaroxaban (an anticoagulant) in addition to standard care, when compared with placebo in addition to standard care, is safe and reduces the risk of the composite (combination of) of cardiovascular death, myocardial infarction (heart attack), or ischaemic stroke (death of localised blood cells in brain), defined as "endpoints".Approximately 13,500 patients who have previously been hospitalised for symptoms suggestive of ACS will be recruited globally with approximately 120 patients coming from 20 sites in the UK. Men or women of 18 years or over will be randomised to either the rivaroxaban group (2.5mg twice a day or 5mg twice a day) or the placebo group. Patients will continue to take their current treatment of either aspirin only, or aspirin plus clopidogrel. Patients may be on the study for up to 3 years. The length of the treatment period is not fixed. As the study is event driven, patients will continue treatment until the pre-specified number of endpoints events has been reached. This could be up to 3 years, depending upon enrollment rates and the occurrence of primary efficacy endpoint events.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/73

• Date of REC Opinion

  2 Feb 2009

• REC opinion

  Further Information Favourable Opinion