NSAIDs vs. Coxibs in the Presence of Aspirin
4상
조기 종료
NCT03699293
| 대상 질환 | Rheumatoid Arthritis, Cardiovascular Diseases |
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| 임상 단계 | 4상 |
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| 스폰서 | Platelet and Thrombosis Research, LLC |
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| 상태 | 조기 종료 |
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| 참여자 수 | 8 명 |
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| 중재(약물) | celecoxib 200mg capsule, naproxen sodium 550mg tablet, Aspirin 81mg tablet |
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| 시작일 | 2018년 9월 22일 |
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| 완료일 | 2022년 12월 1일 |
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| 결과 공개일 | 2026년 5월 14일 |
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요약
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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