Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2018-09-22
2019-11-24
Brief Summary
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Detailed Description
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Thirty patients with rheumatoid arthritis who are at high cardiovascular (CV) risk or with established CV disease will be enrolled in the study. Patients taking anticoagulant therapy or any other antiplatelet agent other than aspirin will be excluded.
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. Blood and urine samples will be collected at baseline before the aspirin run in period, 24±4 hr after the last dose of aspirin in the run in period, 24±4 hr after the last dose of the first period study drug and 24±4 hr after the last dose of the second period study drug. Assays for platelet function, biomarkers of inflammation and endothelial function will be performed at these time points.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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)
celecoxib 200mg capsule
celecoxib 200mg twice a day for 4 weeks
Aspirin 81mg tablet
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
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)
naproxen sodium 550mg tablet
naproxen sodium 550mg twice a day for 4 weeks
Aspirin 81mg tablet
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
Interventions
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celecoxib 200mg capsule
celecoxib 200mg twice a day for 4 weeks
naproxen sodium 550mg tablet
naproxen sodium 550mg twice a day for 4 weeks
Aspirin 81mg tablet
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
Exclusion Criteria
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-
18 Years
75 Years
ALL
No
Sponsors
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Inova Health Care Services
OTHER
Responsible Party
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Principal Investigators
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Kevin Bliden, BS, MBA
Role: STUDY_DIRECTOR
Inova Health Care Services
Locations
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Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17-2915
Identifier Type: -
Identifier Source: org_study_id
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