Comparative effect on platelet function of a fixed-dose aspirin and clopidogrel combination versus separate formulations in patients with coronary artery disease: A phase IV, multicenter, prospective, 4-week non-inferiority trial
| Autor: | Cheol Ung Choi, Jun Kwan, Kyung Tae Jung, Dong-Soo Kim, Taehoon Ahn, Woong Gil Choi, Kook Jin Chun, Kwang Soo Cha, Young Dae Kim, Tae Ik Kim, Deok Kyu Cho, Tae Joon Cha, Yong Mo Yang, Jang Ho Bae, Byung Soo Kim, Dong Woon Kim, Wook Bum Pyun, Doo Il Kim, Bum-Kee Hong, Pyung Chun Oh, Dong Woon Jeon |
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| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Ticlopidine Platelet Function Tests medicine.medical_treatment Fixed-dose combination Population Coronary Artery Disease 030204 cardiovascular system & hematology Gastroenterology 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans Prospective Studies cardiovascular diseases 030212 general & internal medicine education Aspirin education.field_of_study business.industry Percutaneous coronary intervention Drug-Eluting Stents Middle Aged Clopidogrel Drug Combinations Treatment Outcome Anesthesia Conventional PCI Platelet aggregation inhibitor Female Cardiology and Cardiovascular Medicine business Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | International Journal of Cardiology. 202:331-335 |
| ISSN: | 0167-5273 |
| Popis: | Background/objectives The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Methods This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100mg and clopidogrel 75mg once daily as separate formulations for >6months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4weeks later. Results A total of 648 patients (the full-analysis population; age, 63.6±9.0years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, −0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4weeks of FDC treatment. Conclusions This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES. |
| Databáze: | OpenAIRE |
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