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NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects with Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease.

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03699293

Background Information

  • The objective of this single site, randomized, crossover study is to evaluate the pharmacodynamics interactions between aspirin, NSAIDS and Coxibs with respect to platelet function, biomarkers of inflammation and endothelial function.
  • Thirty patients with rheumatoid arthritis who are at high cardiovascular (CV) risk or with established CV disease will be enrolled in the study.
  • Patients will be treated with immediate release 81mg aspirin for 4 weeks in the run-in period followed by randomization to celecoxib (200 mg bid) vs. naproxen sodium (550 mg bid) for 4 weeks and then cross over to the other drug for another 4 weeks.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Paul Gurbel, MD

Eligibility Information

  • Subjects diagnosed with rheumatoid arthritis
  • Subjects with cardiovascular disease such as history of prior myocardial infarction, unstable angina, percutaneous coronary intervention, CABG, TIA, ischemic stroke, carotid endarterectomy, or other arterial surgery or angioplasty (which have occurred > 3 months prior to screening visit); diabetes mellitus type 1 or 2; symptomatic peripheral arterial disease; history of stable angina
  • Subjects with (3) increased risks of cardiovascular disease such as over 55 years of age; history of hypertension; history of dyslipidemia; current smoker (defined as any cigarette smoking within the past 30 days); family history of premature CV disease; obesity (BMI>30)

Ineligibility Information

  • 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
  • Current anticoagulation therapy within 14 days of screening visit
  • Current antiplatelet therapy except for aspirin within 14 days of screening visit
  • Uncontrolled hypertension during screening visit
  • Uncontrolled arrhythmia <3 months from screening visit
  • NYHA class III-IV heart failure
  • On fluconazole, or lithium therapy
  • Malignancy <5 years before screening visit
  • GI ulceration < 60 days before screening visit
  • GI bleeding, perforation, obstruction < 6 months of screening visit
  • Known, active, significant GI, hepatic, renal, or coagulation disorders
  • Allergy or hypersensitivity to any of the study medications and its components (i.e. sulfonamides)
  • History of any disease or condition that, in the opinion of the investigator would place the subject at an unacceptable risk to participate in this study
  • Subjects who are legally institutionalized. Subjects who are pregnant or lactating
  • Female subjects who are unwilling to use at least 1 effective birth control method, unless the subject is sterilized or postmenopausal