Bayer has announced the start of one of the largest clinical studies ever conducted to examine the benefits of using aspirin in reducing first cardiovascular and cerebrovascular disease events.

The announcement of the trial, called ARRIVE, was made at the European Society of Cardiology congress in Vienna, Austria. The study is being conducted in five countries – Germany, Italy, Spain, the UK and the USA – over a five-year period, and will look at the effects of daily low-dose aspirin in reducing the occurrence of initial fatal and non-fatal heart attacks and strokes in patients at moderate risk.

Investigators are now enrolling the first of an estimated 12,000 patients and more than 400 sites will be involved in the trial. Michael Gaziano of the Brigham and Women's Hospital in Boston, USA, the chairman of the committee overseeing the study, said: "We expect to significantly expand the existing strong body of evidence supporting use of aspirin for primary prevention of cardiovascular disease events - this time in a moderate-risk population."

Bayer added that because ARRIVE is one of the largest trials ever to study the effects of aspirin in preventing primary CVD events in a population at moderate risk, “a critical success factor for the trial is the recruitment of appropriate patients across multiple countries” and is refining the methodology so that it can be used in routine practice. At least 20 million people survive heart attacks and strokes every year and many require “continuing, costly care and are at high risk for recurrences and death,” said Wes Cetnarowski, senior vice president, Bayer Global R&D. “That is why it is so important to prevent a first CVD event”.

According to the World Health Organisation, heart disease and stroke are the leading causes of death worldwide, accounting for 17.5 million, or 30%, of all deaths each year. In addition, “the related financial burdens are enormous”, said Bayer, adding that in the European Union alone, annual expenses associated with cardiovascular disease were estimated at 169 billion euros in 2006.