Painkiller showdown: which is safer for the heart?
NCT ID NCT03699293
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two common pain relievers—celecoxib (a Coxib) and naproxen (an NSAID)—affect blood clotting in people with rheumatoid arthritis who also have heart disease or are at high risk for it. All participants took low-dose aspirin daily. The goal was to see if one pain reliever interfered more with aspirin's blood-thinning effects. Only 8 people enrolled before the study was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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8 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Jan 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sinai Hospital
Baltimore, Maryland, 21215, United States
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Other studies related to the condition(s) this trial covers.
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