• J Am Geriatr Soc · May 1991

    Randomized Controlled Trial Comparative Study Clinical Trial

    Rationale for a primary prevention study using low-dose aspirin to prevent coronary and cerebrovascular disease in the elderly.

    • C A Silagy, J J McNeil, C J Bulpitt, G A Donnan, A M Tonkin, and B Worsam.
    • Department of Social and Preventive Medicine, Monash University, Prahran, Victoria, Australia.
    • J Am Geriatr Soc. 1991 May 1; 39 (5): 484-91.

    AbstractThe 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.

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