title: Rationale for a primary prevention study using low-dose aspirin to prevent coronary and cerebrovascular disease in the elderly.
abstract: The benefits of prophylactic aspirin therapy to prevent cardiovascular and cerebrovascular disease in asymptomatic individuals remains unclear. The rationale for developing a multicentered, double-blind, placebo-controlled clinical trial to determine whether low-dose aspirin (100 mg daily) prevents cardiovascular and cerebrovascular morbidity and mortality in persons aged 70 years and over with no evidence of pre-existing cardiovascular or cerebrovascular disease is described. Sample size calculations have indicated that 15,000 subjects would be required over a 4-year follow-up period in order to demonstrate a 20% reduction in overall cardiovascular mortality at the 0.01 level with a power of 0.8. Such a large-scale community-based clinical trial has never been conducted in Australia in this age group. Therefore the PACE (prevention by low-dose aspirin of cardiovascular disease in the elderly) pilot study has been developed to test recruitment strategies and methods and ascertaining disease end-points.
authors.affiliation: Department of Social and Preventive Medicine, Monash University, Prahran, Victoria, Australia.
authors.forename: C A
authors.initials: CA
authors.lastname: Silagy
authors.forename: J J
authors.initials: JJ
authors.lastname: McNeil
authors.forename: C J
authors.initials: CJ
authors.lastname: Bulpitt
authors.forename: G A
authors.initials: GA
authors.lastname: Donnan
authors.forename: A M
authors.initials: AM
authors.lastname: Tonkin
authors.forename: B
authors.initials: B
authors.lastname: Worsam
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D003327:Coronary Disease / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011322:Primary Prevention / Q000379:methods* / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic
chemical_list: D001241:Aspirin