Rheumatoid ArthritisPhase 4NCT03699293
NSAIDs vs. Coxibs in the Presence of Aspirin
A Phase 4 study testing celecoxib 200mg capsule, naproxen sodium 550mg tablet and Aspirin 81mg tablet in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by Platelet and Thrombosis Research, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Cardiovascular Diseases
- What is being tested?
- celecoxib 200mg capsule, naproxen sodium 550mg tablet and Aspirin 81mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2018to 1 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Qualified patients should have all 4 main criteria
- 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.
Exclusion Criteria: Subjects with any of the following criteria will be excluded from this study:
- Unstable angina, MI, CVA, CABG <3 months from screening visit
- Planned coronary, cerebrovascular, or peripheral revascularization
- Undergone major surgery within 3 months prior to screening visit or has planned major surgery during the study period
- Uncontrolled hypertension (SBP >190, DBP >100 mm Hg) during screening visit
- Uncontrolled arrhythmia < 3 months from screening visit
- NYHA class III-IV heart failure or if available, ejection fraction ≤ 35 %
- Within 6 months prior to screening visit, a history of ACS or hospitalization for heart failure
- Oral corticosteroid, prednisone (or equivalent) > 20 mg daily
- Anticoagulation therapy
- Antiplatelet therapy except for aspirin
- GI ulceration < 60 days before screening visit
- GI bleeding, perforation, obstruction < 6 months of screening visit
- Inflammatory bowel disease, diverticulitis active < 6 months of screening visit
- AST, ALT, or BUN >2x the upper limit normal (within 30 days prior to screening visit)
- Creatinine level >1.7 mg/dL in men, 1.5 mg/dL in women (within 30 days prior to screening visit)
- On fluconazole, methotrexate, or lithium therapy
- Malignancy < 5 years before screening visit
- Other known, active, significant GI, hepatic, renal, or coagulation disorders
- Allergy, allergic-type reactions or hypersensitivity (e.g. asthma, urticaria, etc.) to any of the study medications and its components (i.e. sulfonamides)
- 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
- 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
- Subjects who are legally institutionalized
- Lactating females or females of childbearing potential except for those who are surgically sterile or postmenopausal-
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Cardiovascular Diseases
- Being tested
- celecoxib 200mg capsule, naproxen sodium 550mg tablet, Aspirin 81mg tablet
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib 200mg capsuleDrug
Also called Celebrex
celecoxib 200mg twice a day for 4 weeks
naproxen sodium 550mg tabletDrug
Also called Aleve, Naprosyn
naproxen sodium 550mg twice a day for 4 weeks
Aspirin 81mg tabletDrug
Also called Bayer Aspirin
81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
| Study group | Role | What they receive |
|---|---|---|
| ASA and Celecoxib | Active comparator | Take celecoxib 200mg capsule twice a day and aspirin 81mg tablet once a day for 4 weeks (after completion of the run-in period) Receives: Drug: celecoxib 200mg capsule; Drug: Aspirin 81mg tablet |
| ASA and Naproxen | Active comparator | Take naproxen sodium 550mg tablet twice a day and aspirin 81mg tablet once a day (after completion of the run-in period) Receives: Drug: naproxen sodium 550mg tablet; Drug: Aspirin 81mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
Percent change in AA-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma.
Measurements were obtained at:
- End of 4-week aspirin 81 mg daily run-in period (baseline)
- After completion of the first 4-week treatment period following randomization
- After completion of the second 4-week treatment period (crossover period)
Aspirin 81 mg daily was administered during the run-in period and continued throughout the study.
Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design.
The primary analysis was performed within-subject, comparing platelet aggregation during celecoxib exposure versus naproxen exposure.
Measured: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
Change in Collagen-induced Platelet Aggregation (%)
Percent change in collagen-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma.
Measurements were obtained at:
- End of aspirin 81 mg daily run-in period (baseline)
- After completion of the first 4-week treatment period following randomization
- After completion of the second 4-week treatment period (crossover period)
Aspirin 81 mg daily was continued throughout the study.
Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design.
The primary analysis compared within-subject differences between celecoxib and naproxen exposure periods.
Measured: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
Percent change in ADP-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma.
Measurements were obtained at:
- End of 4-week aspirin 81 mg daily run-in period (baseline)
- After completion of the first 4-week treatment period following randomization
- After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study.
This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods.
The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Measured: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.
Change in Epinephrine-induced Platelet Aggregation (%)
Percent change in epinephrine induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma.
Measurements were obtained at:
- End of 4-week aspirin 81 mg daily run-in period (baseline)
- After completion of the first 4-week treatment period following randomization
- After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study.
This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods.
The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Measured: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start22 Sep 2018
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Why it stopped: Our group moved from Inova Heart and Vascular institute to Sinai Hospital with Platelet and Thrombosis, LLC taking over sponsorship. Study was then IRB approved at Sinai on March, 2020 but closed prior to any additional enrolment due to COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Platelet and Thrombosis Research, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Gurbel, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699293
- Sponsor's protocol ID
- 17-2915
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2018
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03699293
- Acronym / sponsor ID
- 17-2915
- Conditions
- Rheumatoid Arthritis, Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our group moved from Inova Heart and Vascular institute to Sinai Hospital with Platelet and Thrombosis, LLC taking over sponsorship. Study was then IRB approved at Sinai on March, 2020 but closed prior to any additional enrolment due to COVID.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Platelet and Thrombosis Research, LLCUniversity, hospital or other
- Study start
- 22 Sep 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ASA and Celecoxib | Active comparator | Drug: celecoxib 200mg capsule, Drug: Aspirin 81mg tabletTake celecoxib 200mg capsule twice a day and aspirin 81mg tablet once a day for 4 weeks (after completion of the run-in period) |
| ASA and Naproxen | Active comparator | Drug: naproxen sodium 550mg tablet, Drug: Aspirin 81mg tabletTake naproxen sodium 550mg tablet twice a day and aspirin 81mg tablet once a day (after completion of the run-in period) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib 200mg capsuleAlso: Celebrexcelecoxib 200mg twice a day for 4 weeks | Drug | ASA and Celecoxib |
| naproxen sodium 550mg tabletAlso: Aleve, Naprosynnaproxen sodium 550mg twice a day for 4 weeks | Drug | ASA and Naproxen |
| Aspirin 81mg tabletAlso: Bayer Aspirin81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period | Drug | ASA and Celecoxib, ASA and Naproxen |
Primary outcome
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
Time frame: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
Percent change in AA-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design. The primary analysis was performed within-subject, comparing platelet aggregation during celecoxib exposure versus naproxen exposure.
Change in Collagen-induced Platelet Aggregation (%)
Time frame: End of 4-week aspirin run-in period and after completion of each 4-week treatment period
Percent change in collagen-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was continued throughout the study. Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design. The primary analysis compared within-subject differences between celecoxib and naproxen exposure periods.
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
Time frame: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.
Percent change in ADP-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods. The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Change in Epinephrine-induced Platelet Aggregation (%)
Time frame: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.
Percent change in epinephrine induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods. The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Gurbel, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing celecoxib 200mg capsule, naproxen sodium 550mg tablet and Aspirin 81mg tablet in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by Platelet and Thrombosis Research, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation (time frame: End of 4-week aspirin run-in period and after completion of each 4-week treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.