NCT01101035.

Trial name or title	A Multicenter, Randomized, Active‐Control, Phase 3B Study to Evaluate the Cardiovascular harms of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
Methods	Phase 3, randomised, double‐blind, parallel assignment harms trial. 60 months multicentre study. Estimated Enrollment 240.
Participants	Inclusion criteria: ≥ 50 years old; a major cardiovascular or cerebrovascular disease (MI, unstable angina, cardiac or cerebrovascular revascularization procedure, stroke, hospitalised for transient Ischaemic attack, peripheral vascular disease, diabetes mellitus with evidence of micro‐ or macrovascular disease); ACR criteria for gout; serum uric acid level ≥ 7.0 mg/dL at the Day ‐7 Visit OR ≥ 6.0 mg/dL at the Day ‐7 Visit AND inadequately controlled gout Exclusion criteria: secondary hyperuricaemia; on uric acid‐lowering therapy; xanthinuria; known hypersensitivity to any component of the febuxostat or allopurinol formulation; active peptic ulcer disease; cancer within 5 years prior to the first dose of study medication; MI or stroke within 60 days prior to the Screening visit; ALT and/or AST > 2.0 times the upper limit of normal; eCLcr < 30 mL/min; known history of hepatitis B, hepatitis C or HIV; history of drug abuse or a history of alcohol abuse within 5 years prior to the Screening; more than14 alcoholic beverages per week; received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study; required to take excluded medications
Interventions	Patients will be randomised to 2 groups: 1. Febuxostat 40 mg/day or 80 mg/day (dependent on serum uric acid levels) 2. Allopurinol 200 mg/day to 600 mg/day (dependent on renal function)
Outcomes	Primary Outcome Measures: ‐ First occurrence of any event in the predefined Major Adverse Cardiovascular Events Composite (Cardiovascular death, Non‐fatal Myocardial Infarction, Nonfatal Stroke and Unstable Angina with Urgent Coronary Revascularization) Secondary Outcome Measures: ‐ First occurrence of any Antiplatelet Trialists' Collaborative Event (Cardiovascular Death, Non‐fatal Myocardial Infarction or Non‐fatal Stroke) ‐ First occurrence of Cardiovascular Death death ‐ First occurrence of Non‐fatal Myocardial Infarction ‐ First occurrence of Non‐fatal stroke ‐ First occurrence of Unstable Angina with Urgent Coronary Revascularization
Starting date	May 2010
Contact information	Takeda Study Registration Call Center 800‐778‐2860 medicalinformation@tpna.com
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