Inova Health Care Services
The objectives of this single site, randomized, crossover study is to evaluate the pharmacodynamic interactions between aspirin, NSAIDs and Coxibs with respect to platelet function, biomarkers of inflammation and endothelial function.
The relative cardiovascular safety of NSAIDs, particularly among patients with cardiovascular disease (CVD) or at higher CVD risk, has generated considerable concern among both patients and physicians because of knowledge gaps in the evidence relative to comparative safety and pharmacodynamic interactions between aspirin and NSAIDs. In the recently reported PRECISION trial, a moderate dose of celecoxib was found to be noninferior to ibuprofen or naproxen with respect to cardiovascular safety in patients with arthritis at increased CVD risk. At this time, no comparative prior data are available…
Inclusion Criteria:Qualified patients should have all 4 main criteria 1. Age 18-75 years of age for patients who regularly use NSAIDs. 2. Age 18-65 years of age for patients who do not regularly use NSAIDs 3. Able to give informed consent 4. Subjects with CVD or increased CV risk. Please see definitions for each criteria below: * Increased CV risk (Subjects should have at least 3 of the following) * \> 55 years of age * Hypertension * Dyslipidemia (LDL \> 160 mg/dL or HDL \< 40 mg/dL in females and \< 35 mg/dL in males or subjects currently receiving lipid lowering therapy…
celecoxib 200mg twice a day for 4 weeks
naproxen sodium 550mg twice a day for 4 weeks
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
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