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Table 1 ASPIRED eligibility criteria

From: ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial

Inclusion criteria Exclusion criteria
• Adenoma removed during qualifying endoscopy (as confirmed by pathology)
• Not currently taking aspirin (any dose) within the last 6 months
• Age 18–80 years
• Able to swallow pills
• Ability to understand and the willingness to sign a written Informed Consent Document
• ECOG performance status ≤2
• (Karnofsky Index score ≥60%)
• Any adenoma that was not completely removed during previous colonoscopy
• Known diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
• Diagnosis of inflammatory bowel disease, liver or kidney disease, or bleeding diathesis
• Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestinal, colon, pancreatic), or any diagnosis of other cancers (with the exception of non-melanomatous neoplasia of skin) in which there has been any active treatment within the last 3 years
• Use of any nonaspirin, nonsteroidal anti-inflammatory drug (NSAID) at any dose at least 3 times/week during the 2 months prior to randomization
• History of aspirin intolerance, bleeding diathesis, peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin
• Taking any anticoagulant agent (e.g., warfarin) or antiplatelet agent (e.g., clopidogrel)
• Receiving any other investigational agents
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding
  1. ECOG, Eastern Cooperative Oncology Group