NSAIDs vs. Coxibs in the Presence of Aspirin
Phase 4
Terminated
NCT03699293
| Condition | Rheumatoid Arthritis, Cardiovascular Diseases |
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| Phase | Phase 4 |
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| Sponsor | Platelet and Thrombosis Research, LLC |
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| Status | Terminated |
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| Enrollment | 8 participants |
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| Interventions | celecoxib 200mg capsule, naproxen sodium 550mg tablet, Aspirin 81mg tablet |
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| Start date | Sep 22, 2018 |
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| Completion date | Dec 1, 2022 |
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| Results posted | May 14, 2026 |
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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.
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
End of 4-week aspirin run-in period and after completion of each 4-week treatment period · Percent Aggregation (%)
| Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium | 2.5 ± 0.7 Percent Aggregation (%) |
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| Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib | 3.3 ± 4.9 Percent Aggregation (%) |
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| Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium | 1.4 ± 1.6 Percent Aggregation (%) |
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| Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib | 3 ± 0 Percent Aggregation (%) |
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| Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium | 6.5 ± 7.8 Percent Aggregation (%) |
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| Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib | 31.5 ± 34.6 Percent Aggregation (%) |
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Change in Collagen-induced Platelet Aggregation (%)
End of 4-week aspirin run-in period and after completion of each 4-week treatment period · Percent Aggregation (%)
| ASA Lead in Followed by ASA + Celecoxib, and Then Crossover to ASA+ Naproxen Arm. | 55.3 ± 20.4 Percent Aggregation (%) |
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| ASA and Naproxen | 68.0 ± 18.4 Percent Aggregation (%) |
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| ASA Lead in Followed by ASA + Celecoxib, and Then Crossover to ASA+ Naproxen Arm. | -0.3 ± 3.7 Percent Aggregation (%) |
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| ASA and Naproxen | -12.5 ± 14.8 Percent Aggregation (%) |
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| ASA Lead in Followed by ASA + Celecoxib, and Then Crossover to ASA+ Naproxen Arm. | -10.7 ± 8.2 Percent Aggregation (%) |
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| ASA and Naproxen | -6 ± 3.1 Percent Aggregation (%) |
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Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
End of 4-week aspirin run-in period and after completion of each 4-week treatment period. · Percent Aggregation (%)
| ASA and Celecoxib | 60.3 ± 11.0 Percent Aggregation (%) |
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| ASA and Naproxen | 64.0 ± 14.4 Percent Aggregation (%) |
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| ASA and Celecoxib | -27 ± 22 Percent Aggregation (%) |
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| ASA and Naproxen | 0.5 ± 0.7 Percent Aggregation (%) |
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| ASA and Celecoxib | -6.6 ± 6.7 Percent Aggregation (%) |
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| ASA and Naproxen | -3 ± 8.5 Percent Aggregation (%) |
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