NSAIDs vs. Coxibs in the Presence of Aspirin
Фаза 4
Прекращено
NCT03699293
| Заболевание | Rheumatoid Arthritis, Cardiovascular Diseases |
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| Фаза | Фаза 4 |
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| Спонсор | Platelet and Thrombosis Research, LLC |
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| Статус | Прекращено |
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| Участники | 8 участн. |
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| Вмешательство | celecoxib 200mg capsule, naproxen sodium 550mg tablet, Aspirin 81mg tablet |
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| Дата начала | 22.09.2018 |
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| Дата завершения | 1.12.2022 |
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| Публикация результатов | 14.05.2026 |
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Кратко
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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