Coronary Artery Disease - PRECISION
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Trial Sponsor
Pfizer
Principal Investigator
Holly Novak, MD
Trial Name
A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
Purpose
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribed traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
Phase
Phase IV
Study Type
Interventional
Study Design
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Study Arms
3
Expected Enrollment
20000
Study Start
October 2006
Expected Completion
February 2013
Primary Outcome Measures
- The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint) up to 18 months.
Secondary Outcome Measures
- The occurrence of Clinical Significant Gastrointestinal Events up to 18 months
- Patient's Assessment of Arthritis Pain up to 18 months
- The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA up to 18 months
Eligibility
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.
Exclusion Criteria
- Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
- Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
- Subjects require treatment with aspirin > 325 mg /day
- Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
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