Rheumatoid Arthritis (RA) Clinical Trials

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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

Who is this study for? Patients with Rheumatoid Arthritis, Cardiovascular Diseases
What treatments are being studied? Aspirin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years of age for patients who regularly use NSAIDs.

• Age 18-65 years of age for patients who do not regularly use NSAIDs

• Able to give informed consent

• 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 as standard of care (i.e. statin drugs, prescription ω 3-acid ethyl esters, fibrates or prescription niacin \[≥1,000 mg/d\])

∙ Family history of premature CV disease (MI, angina pectoris, heart failure, cardiac death or coronary revascularization, stroke, carotid endarterectomy, or other arterial surgery or angioplasty for atherosclerotic vascular disease in a parent, grandparent, or sibling with symptom onset or diagnosis before age 55 y for males and 65 y for females)

∙ Current smoker

∙ Left ventricular hypertrophy

∙ Documented ankle brachial index of \<0.9

∙ History of microalbuminuria, urine protein-creatinine ratio of \>2

⁃ CV disease (defined as one of the following):

• Calcium score of \>0

∙ ≥ 50 % occlusion of a coronary artery by angiography

∙ ≥ 50 % occlusion of a carotid artery by angiography or ultrasound

∙ History of stable angina

∙ Symptomatic peripheral arterial disease

∙ Prior MI, 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 (considered a CV disease equivalent).

⁃ Clinical diagnosis of rheumatoid arthritis, as determined by individual patient and physician, requiring daily treatment with NSAIDs.

Locations
United States
Virginia
Inova Heart and Vascular Institute
RECRUITING
Falls Church
Contact Information
Primary
Kevin Bliden, BS, MBA
kevin.bliden@inova.org
(703) 776-7702
Backup
Emiliya Bakalska, BA
emiliya.bakalska@inova.org
(410) 367-2592
Time Frame
Start Date: 2018-09-22
Estimated Completion Date: 2019-11-24
Participants
Target number of participants: 30
Treatments
Active_comparator: ASA and Celecoxib
Take celecoxib 200mg capsule twice a day and aspirin 81mg tablet once a day for 4 weeks (after completion of the run-in period)
Active_comparator: ASA and Naproxen
Take naproxen sodium 550mg tablet twice a day and aspirin 81mg tablet once a day (after completion of the run-in period)
Related Therapeutic Areas
Sponsors
Leads: Inova Health Care Services

This content was sourced from clinicaltrials.gov