NSAIDs vs. Coxibs in the Presence of Aspirin
第4相
早期終了
NCT03699293
| 対象疾患 | Rheumatoid Arthritis, Cardiovascular Diseases |
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| 相 | 第4相 |
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| スポンサー | Platelet and Thrombosis Research, LLC |
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| ステータス | 早期終了 |
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| 参加者数 | 8 名 |
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| 介入（薬剤） | celecoxib 200mg capsule, naproxen sodium 550mg tablet, Aspirin 81mg tablet |
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| 開始日 | 2018年9月22日 |
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| 完了日 | 2022年12月1日 |
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| 結果公開日 | 2026年5月14日 |
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概要
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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