NSAIDs vs. Coxibs in the Presence of Aspirin

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03699293
• Date of registration: 21/09/2018
• Prospective Registration: Yes
• Primary sponsor: Inova Health Care Services
• Public title: NSAIDs vs. Coxibs in the Presence of Aspirin
• Scientific title: 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
• Date of first enrolment: September 22, 2018
• Target sample size: 30
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03699293
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Kevin Bliden, BS, MBA
• Affiliation: Inova Health Care Services

• Name: Andrea Fitzgerald, RN, MS

• Name: Kevin Bliden, BS, MBA

Key inclusion & exclusion criteria

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 as standard of
care (i.e. statin drugs, prescription ? 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.

Exclusion Criteria: Subjects with any of the following criteria will be excluded from this
study:

1. Unstable angina, MI, CVA, CABG <3 months from screening visit

2. Planned coronary, cerebrovascular, or peripheral revascularization

3. Undergone major surgery within 3 months prior to screening visit or has planned major
surgery during the study period

4. Uncontrolled hypertension (SBP >190, DBP >100 mm Hg) during screening visit

5. Uncontrolled arrhythmia < 3 months from screening visit

6. NYHA class III-IV heart failure or if available, ejection fraction = 35 %

7. Within 6 months prior to screening visit, a history of ACS or hospitalization for
heart failure

8. Oral corticosteroid, prednisone (or equivalent) > 20 mg daily

9. Anticoagulation therapy

10. Antiplatelet therapy except for aspirin

11. GI ulceration < 60 days before screening visit

12. GI bleeding, perforation, obstruction < 6 months of screening visit

13. Inflammatory bowel disease, diverticulitis active < 6 months of screening visit

14. AST, ALT, or BUN >2x the upper limit normal (within 30 days prior to screening visit)

15. Creatinine level >1.7 mg/dL in men, 1.5 mg/dL in women (within 30 days prior to
screening visit)

16. On fluconazole, methotrexate, or lithium therapy

17. Malignancy < 5 years before screening visit

18. Other known, active, significant GI, hepatic, renal, or coagulation disorders

19. Allergy, allergic-type reactions or hypersensitivity (e.g. asthma, urticaria, etc.) to
any of the study medications and its components (i.e. sulfonamides)

20. History of any disease of condition that, in the opinion of the investigator would
place the subject at an unacceptable risk to participate in this study

21. Any clinically relevant abnormal findings in physical examination, vital signs, or
previous laboratory works that, in the opinion of the investigator, may compromise the
safety of the subject to participate

22. Subjects who are legally institutionalized

23. Lactating females or females of childbearing potential except for those who are
surgically sterile or postmenopausal-



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Cardiovascular Diseases

Intervention(s)

Drug: Aspirin 81mg tablet

Drug: celecoxib 200mg capsule

Drug: naproxen sodium 550mg tablet

Primary Outcome(s)

Platelet aggregation [Time Frame: 12 weeks]

Secondary Outcome(s)

Endothelial function by EndoPAT [Time Frame: 12 weeks]

Soluble markers of circulating adhesion molecules (VCAM, ICAM). [Time Frame: 12 weeks]

Urine 8 iso prostaglandin [Time Frame: 12 weeks]

Urine thromboxane [Time Frame: 12 weeks]

Oxidized LDL [Time Frame: 12 weeks]

hsCRP [Time Frame: 12 weeks]

Serum TxB2 [Time Frame: 12 weeks]

Secondary ID(s)

17-2915

Source(s) of Monetary Support

Please refer to primary and secondary sponsors