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Trial record 63 of 87 for:    ASPIRIN AND thromboxane

NSAIDs vs. Coxibs in the Presence of Aspirin

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ClinicalTrials.gov Identifier: NCT03699293
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Cardiovascular Diseases Drug: celecoxib 200mg capsule Drug: naproxen sodium 550mg tablet Drug: Aspirin 81mg tablet Phase 4

Detailed Description:

The relative cardiovascular safety of NSAIDs, particularly among patients with cardiovascular disease (CVD) or at higher CVD risk, has generated considerable concern among both patients and physicians because of knowledge gaps in the evidence relative to comparative safety and pharmacodynamic interactions between aspirin and NSAIDs. In the recently reported PRECISION trial, a moderate dose of celecoxib was found to be noninferior to ibuprofen or naproxen with respect to cardiovascular safety in patients with arthritis at increased CVD risk. At this time, no comparative prior data are available analyzing the effects of NSAIDs vs. Coxibs in the presence of aspirin on 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Qualified 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 before the aspirin run-in period (baseline), 24±4 hrs after the last dose of aspirin in the run-in period, 24±4 hr after the last dose of the study drug in the first period and 24±4 hr after the last dose of the study drug in the second period. Assays for platelet function, biomarkers of inflammation and endothelial function will be performed at these time points
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : September 22, 2018
Estimated Primary Completion Date : September 24, 2019
Estimated Study Completion Date : November 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
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)
Drug: celecoxib 200mg capsule
celecoxib 200mg twice a day for 4 weeks
Other Name: Celebrex

Drug: Aspirin 81mg tablet
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
Other Name: Bayer Aspirin

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)
Drug: naproxen sodium 550mg tablet
naproxen sodium 550mg twice a day for 4 weeks
Other Names:
  • Aleve
  • Naprosyn

Drug: Aspirin 81mg tablet
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
Other Name: Bayer Aspirin




Primary Outcome Measures :
  1. Platelet aggregation [ Time Frame: 12 weeks ]
    Change in platelet aggregation by light transmittance aggregometry between treatment groups


Secondary Outcome Measures :
  1. Serum TxB2 [ Time Frame: 12 weeks ]
    Changes in serum TxB2 between treatment groups

  2. Urine thromboxane [ Time Frame: 12 weeks ]
    Changes in urine thromboxane between treatment groups

  3. Urine 8 iso prostaglandin [ Time Frame: 12 weeks ]
    Changes in urine 8 iso prostaglandin between treatment groups

  4. Endothelial function by EndoPAT [ Time Frame: 12 weeks ]
    Changes in endothelial function by EndoPAT (Endothelial Peripheral Arterial Tone) between treatment groups

  5. Soluble markers of circulating adhesion molecules (VCAM, ICAM). [ Time Frame: 12 weeks ]
    Changes in soluble markers of circulating adhesion molecules (VCAM, and ICAM) between treatment groups

  6. hsCRP [ Time Frame: 12 weeks ]
    Changes in hsCRP between treatment groups

  7. Oxidized LDL [ Time Frame: 12 weeks ]
    Changes in Oxidized LDL between treatment groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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: 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-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699293


Contacts
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Contact: Kevin Bliden, BS, MBA (703) 776-7702 kevin.bliden@inova.org
Contact: Emiliya Bakalska, BA (410) 367-2592 emiliya.bakalska@inova.org

Locations
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United States, Virginia
Inova Heart and Vascular Institute Recruiting
Falls Church, Virginia, United States, 22042
Contact: Andrea Fitzgerald, RN, MS    703-776-3330    andrea.fitzgerald@inova.org   
Contact: Solomon Yeon, MS    (703) 776-4726    solomon.yeaon@inova.org   
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Study Director: Kevin Bliden, BS, MBA Inova Health Care Services

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03699293     History of Changes
Other Study ID Numbers: 17-2915
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Celecoxib
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Cyclooxygenase 2 Inhibitors
Gout Suppressants