RecruitingPhase 4NCT03699293

NSAIDs vs. Coxibs in the Presence of Aspirin

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


Sponsor

Inova Health Care Services

Enrollment

30 participants

Start Date

Sep 22, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing the effects of two different types of anti-inflammatory pain medications — traditional NSAIDs (like ibuprofen) versus COX-2 inhibitors (called Coxibs, like celecoxib) — in patients who also take daily aspirin for heart protection, to better understand their relative risks for stomach bleeding and heart complications. **You may be eligible if...** - You are 18 to 75 years old (or 18 to 65 if you don't regularly use NSAIDs) - You have either established heart or blood vessel disease OR several risk factors for heart disease (such as high blood pressure, high cholesterol, family history, or smoking) - OR you have been diagnosed with rheumatoid arthritis requiring daily NSAID use **You may NOT be eligible if...** - You have severe kidney failure - You have serious liver disease - You have a history of stomach or intestinal bleeding - You have certain heart conditions (like recent heart attack) that make NSAID use unsafe - You are allergic to aspirin or NSAIDs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcelecoxib 200mg capsule

celecoxib 200mg twice a day for 4 weeks

DRUGnaproxen sodium 550mg tablet

naproxen sodium 550mg twice a day for 4 weeks

DRUGAspirin 81mg tablet

81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period


Locations(1)

Inova Heart and Vascular Institute

Falls Church, Virginia, United States

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NCT03699293


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