NSAIDs vs. Coxibs in the Presence of Aspirin

Exclusion Criteria23

• Unstable angina, MI, CVA, CABG \<3 months from screening visit
• Planned coronary, cerebrovascular, or peripheral revascularization
• Undergone major surgery within 3 months prior to screening visit or has planned major surgery during the study period
• Uncontrolled hypertension (SBP \>190, DBP \>100 mm Hg) during screening visit
• Uncontrolled arrhythmia \< 3 months from screening visit
• NYHA class III-IV heart failure or if available, ejection fraction ≤ 35 %
• Within 6 months prior to screening visit, a history of ACS or hospitalization for heart failure
• Oral corticosteroid, prednisone (or equivalent) \> 20 mg daily
• Anticoagulation therapy
• Antiplatelet therapy except for aspirin
• GI ulceration \< 60 days before screening visit
• GI bleeding, perforation, obstruction \< 6 months of screening visit
• Inflammatory bowel disease, diverticulitis active \< 6 months of screening visit
• AST, ALT, or BUN \>2x the upper limit normal (within 30 days prior to screening visit)
• Creatinine level \>1.7 mg/dL in men, 1.5 mg/dL in women (within 30 days prior to screening visit)
• On fluconazole, methotrexate, or lithium therapy
• Malignancy \< 5 years before screening visit
• Other known, active, significant GI, hepatic, renal, or coagulation disorders
• Allergy, allergic-type reactions or hypersensitivity (e.g. asthma, urticaria, etc.) to any of the study medications and its components (i.e. sulfonamides)
• History of any disease of condition that, in the opinion of the investigator would place the subject at an unacceptable risk to participate in this study
• Any clinically relevant abnormal findings in physical examination, vital signs, or previous laboratory works that, in the opinion of the investigator, may compromise the safety of the subject to participate
• Subjects who are legally institutionalized
• Lactating females or females of childbearing potential except for those who are surgically sterile or postmenopausal-