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Rivaroxaban clinical trial halted following increased fatalities

The MHRA has released a concerning alert regarding the safety of Rivaroxaban (trade name Xeralto) in a multi-national clinical trial involving patients who have undergone surgery for transcatheter aortic valve replacement (TAVR).

Posted on 12 October 2018

Rivaroxaban is a type of anti-coagulant medication that is used to prevent blood clotting. It is often used to reduce the risk of blood clots forming following hip or knee replacement surgery, or generally to reduce the risk of embolisms, DVTs or strokes

The study – named GALILEO – is reported to have enrolled 1,644 participants across a number of sites in the US and Europe. Preliminary results indicate that 117 trial participants who were given Rivaroxaban died or suffered a “first thromboembolic event”, an additional 56 people died from “all-causes”, and 36 people suffered a “primary bleeding event”. The incidence of all-cause death and primary bleed events was at least double that seen in the comparator group (who were treated with a different type of anti-coagulant). 

As a result of these preliminary findings, the Data Safety Monitoring Board (DSMB) recommended that the trial be halted in August 2018. Consequently, the MHRA’s safety alert (published on 11 October 2018) confirms that, “rivaroxaban is not authorised for thromboprophylaxis in patients with prosthetic heart valves, including patients who have undergone TAVR…”.

Gene Matthews, a partner in the consumer law and product safety department at Leigh Day who specialises in clinical trial issues commented: 

“Whilst it is reassuring that the issues in the GALILEO trial appear to have been identified and thereafter appropriate action swiftly taken to prevent harm being caused to the general population, it seems that a number of individuals may have been exposed to an unacceptable risk of harm during their participation in this clinical trial. If that has happened in the UK, it is imperative that those people are properly compensated for what they have suffered."  

If you wish to contact a legal advisor about Rivaroxaban contact Gene Matthews or Stuart Warmington.