UF seeking older adults for international aspirin trial

June 29, 2010

GAINESVILLE, Fla., — The University of Florida is recruiting men and women 70 and older to take part in a large international study of whether daily low-dose aspirin can help stave off disabling conditions and increase life expectancy among healthy seniors.

The American Heart Association recommends the use of aspirin to prevent recurrence of heart attack and stroke. Physicians have extended the therapy as a preventive measure against heart attack, stroke, certain cancers and dementia for people who are otherwise healthy. That practice has been called into question, however, as the benefit for people who have not had cardiovascular disease is unclear.

Previous studies on aspirin therapy have been mainly among middle-aged individuals and those who have a history of cardiovascular disease. But among the elderly, conditions other than cardiovascular disease might be of consequence. Thus a fuller understanding of the potential effects of the therapy in that population is needed.

The Aspirin in Reducing Events in the Elderly — or ASPREE — study is the first to examine whether the potential benefits of low-dose aspirin outweigh the associated health risks for people 70 and older.

Aspirin therapy can have negative effects among older adults, mainly because of the potential to cause bleeding. It could result in severe gastrointestinal bleeding and hemorrhagic stroke.

The five-year study of 19,000 older adults will be conducted at universities and clinics around the United States and Australia. In the U.S., 6,500 individuals from Florida, Alabama, Illinois, Iowa, Michigan, Minnesota, New Mexico, North Carolina, Pennsylvania, Rhode Island and Texas will participate. The other 12,500 participants will be in Australia.

To be eligible for the study, individuals must be 70 years or older and free from cardiovascular disease, allergies to aspirin, high risk of bleeding, and disability or dementia, among other criteria.

Participants will be in the study for five years and will be randomly assigned to receive either a daily dose of aspirin or a matching pill that does not contain aspirin. They will not be told which formulation they receive, and neither will study staff. The aspirin and placebo are provided by Bayer Schering Pharma.

Initially participants will complete questionnaires and have a medical evaluation that includes physical examination and routine laboratory studies. They will also be tested for certain health markers as well as functional and cognitive ability, and will receive telephone calls every three months for follow-up. Participants will be asked to return to the study office on a yearly basis for repeat physical examinations and testing to monitor for changes during the study.

Participants will be compensated for their time.

Seniors 70 years or older who are interested in enrolling in the trial or getting more information should call 352-273-5919 or 866-386-7730 and ask about “The ASPREE study.”