ASPREE Study: Asprin in Reducing Events in the Elderly

Study ID
STU 102010-077

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • CTRC Outpatient
  • Clements University Hospital
  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern-Other
  • Zale Lipshy University Hospital

Contact
Ifeoma Achebe
214/534-7901
ifeoma.achebe@utsouthwestern.edu

Principal Investigator
Shawna Nesbitt, M.D.

Summary

aSPRee is a double-blind, randomized, placebo-controlled primary prevention trial designed to assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy african american and Hispanic men and women 65 years of age and over, and all other men and women 70 years of age and over.
approximately, 19,000 people from australia and the united States are expected to take part in this study. in the united States approximately 6,500 people will be enrolled across about 25 sites and about 4,500 of them will be minorities. We expect to consent 900 people to enroll up to 600 people in the study here at uTSW.
The study arms in the trial are placebo and active treatment with 100mg enteric coated aspirin. The primary endpoints in the trial are death from any cause or incident dementia or persistent physical disability. Secondary endpoints include: all-cause mortality, fatal and non-fatal cardiovascular events (coronary heart disease death, non-fatal Mi, fatal and non-fatal stroke, and hospitalization for heart failure), Fatal and non-fatal cancer, excluding melanoma, dementia, mild cognitive impairment, physical disability, and major hemorrhagic events. These secondary endpoints may contribute to the primary endpoints of the aSPRee study. The entire project is 7 years with 2 years for recruitment and up to 6 years follow-up.

uPDaTe 7/29/13 ReCRuiT Study Design: ReCRuiT is a randomized phase iii trial of a recruitment intervention with clinical trial site as the unit of randomization. Voluntary patient satisfaction surveys will be handed to all study paticipants at the end of each study visit. The willing participants will mail the completed surveys directly to The ReCRuiT Coordinating Center at the university of Texas School of Public Health.

Participant Eligibility

Inclusion Criteria:

African American and Hispanic men and women 65 years of age and over, all other men and women 70 years of age and over.