Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate with Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-08-03

AUTHORS

Sahmin Lee, Hae-Young Lee, Kyung-Woo Park, Hyun-Jae Kang, Bon-Kwon Koo, Hyo-Soo Kim, Dong-Ju Choi, Myung-A Kim, Byung-Hee Oh

ABSTRACT

BackgroundClopidogrel napadisilate has better clopidogrel stability than clopidogrel bisulfate. There are no data, however, on the antiplatelet efficacy and tolerability of clopidogrel napadisilate in coronary artery disease (CAD) patients.ObjectiveThe aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for 4 weeks to CAD patients who had been treated with a drug-eluting stent more than 12 months prior and had remained in a stable condition with a single antiplatelet agent, aspirin.MethodsThis study was a prospective, randomized, double-blind, double-dummy, parallel-group, phase IV clinical trial. A total of 162 patients were prospectively recruited from three centers. The subjects were randomized to either the test group that was treated with 75 mg of clopidogrel napadisilate once daily or to the control group that was treated with 75 mg of clopidogrel bisulfate once daily. The primary outcome was the percent inhibition of the platelet aggregation change after the medication, as assessed by a VerifyNow™ P2Y12 assay. The secondary outcome was the change in P2Y12 reaction units (PRUs) from the baseline to the end of 4 weeks of treatment. The prevalence of adverse events was assessed at each visit through a direct interview.ResultsThe mean increase in the percent inhibition after 4 weeks of treatment was 19.4 % in the clopidogrel napadisilate group and 19.5 % in the clopidogrel bisulfate group. The lower bound of the 95 % two-sided confidence interval for the difference in the change between the two groups (-5.46) was greater than the pre-defined non-inferiority margin of (-10.5). Therefore, clopidogrel napadisilate was deemed non-inferior to clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation. The PRU decreased by 73.1 ± 30.7 in the clopidogrel napadisilate group, which decreased by -7.8 more than in the clopidogrel bisulfate group (65.3 ± 62.1); but the difference between the two groups was statistically insignificant (p = 0.435). There was no significant difference in the drug-related adverse events between the two groups (12.3 vs. 10.1 %; p = 0.804).ConclusionThe platelet inhibitory efficacy of clopidogrel napadisilate is not inferior to that of clopidogrel bisulfate. There were also no statistically significant differences between the two treatment groups in the safety analyses. Therefore, clopidogrel napadisilate can be a suitable alternative to clopidogrel bisulfate in stable CAD patients who have undergone a drug-eluting stent placement.Clinical Trial RegistrationRegistered at ClinicalTrials.gov as NCT01830491. More... »

PAGES

413-424

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40256-013-0039-y

DOI

http://dx.doi.org/10.1007/s40256-013-0039-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1010160542

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23913405


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22 schema:description BackgroundClopidogrel napadisilate has better clopidogrel stability than clopidogrel bisulfate. There are no data, however, on the antiplatelet efficacy and tolerability of clopidogrel napadisilate in coronary artery disease (CAD) patients.ObjectiveThe aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for 4 weeks to CAD patients who had been treated with a drug-eluting stent more than 12 months prior and had remained in a stable condition with a single antiplatelet agent, aspirin.MethodsThis study was a prospective, randomized, double-blind, double-dummy, parallel-group, phase IV clinical trial. A total of 162 patients were prospectively recruited from three centers. The subjects were randomized to either the test group that was treated with 75 mg of clopidogrel napadisilate once daily or to the control group that was treated with 75 mg of clopidogrel bisulfate once daily. The primary outcome was the percent inhibition of the platelet aggregation change after the medication, as assessed by a VerifyNow™ P2Y12 assay. The secondary outcome was the change in P2Y12 reaction units (PRUs) from the baseline to the end of 4 weeks of treatment. The prevalence of adverse events was assessed at each visit through a direct interview.ResultsThe mean increase in the percent inhibition after 4 weeks of treatment was 19.4 % in the clopidogrel napadisilate group and 19.5 % in the clopidogrel bisulfate group. The lower bound of the 95 % two-sided confidence interval for the difference in the change between the two groups (-5.46) was greater than the pre-defined non-inferiority margin of (-10.5). Therefore, clopidogrel napadisilate was deemed non-inferior to clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation. The PRU decreased by 73.1 ± 30.7 in the clopidogrel napadisilate group, which decreased by -7.8 more than in the clopidogrel bisulfate group (65.3 ± 62.1); but the difference between the two groups was statistically insignificant (p = 0.435). There was no significant difference in the drug-related adverse events between the two groups (12.3 vs. 10.1 %; p = 0.804).ConclusionThe platelet inhibitory efficacy of clopidogrel napadisilate is not inferior to that of clopidogrel bisulfate. There were also no statistically significant differences between the two treatment groups in the safety analyses. Therefore, clopidogrel napadisilate can be a suitable alternative to clopidogrel bisulfate in stable CAD patients who have undergone a drug-eluting stent placement.Clinical Trial RegistrationRegistered at ClinicalTrials.gov as NCT01830491.
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37 RegistrationRegistered
38 ResultsThe mean increase
39 Secondary outcomes
40 Trial RegistrationRegistered
41 VerifyNow
42 adverse events
43 agents
44 aggregation
45 aggregation changes
46 aim
47 alternative
48 analysis
49 antiplatelet agents
50 antiplatelet effect
51 antiplatelet efficacy
52 artery disease (CAD) patients
53 aspirin
54 assays
55 baseline
56 better clopidogrel stability
57 bisulfate
58 bisulfate group
59 center
60 changes
61 clinical trials
62 clopidogrel bisulfate
63 clopidogrel bisulfate group
64 clopidogrel napadisilate
65 clopidogrel napadisilate group
66 clopidogrel stability
67 combination therapy
68 comparison
69 conditions
70 confidence intervals
71 control group
72 coronary artery disease patients
73 data
74 differences
75 direct interviews
76 disease patients
77 drug-eluting stent placement
78 drug-related adverse events
79 effect
80 effectiveness
81 efficacy
82 end
83 events
84 group
85 increase
86 inhibition
87 inhibitory efficacy
88 intervals
89 interviews
90 margin
91 mean increase
92 medications
93 months
94 napadisilate
95 napadisilate group
96 non-inferiority clinical trial
97 non-inferiority margin
98 outcomes
99 patients
100 percent inhibition
101 phase IV
102 phase IV clinical trial
103 placement
104 platelet aggregation
105 platelet aggregation changes
106 platelet inhibitory efficacy
107 pre-defined non-inferiority margin
108 prevalence
109 primary outcome
110 reaction units
111 respect
112 safety
113 safety analysis
114 significant differences
115 single antiplatelet agent
116 stability
117 stable CAD patients
118 stable conditions
119 stent placement
120 study
121 subjects
122 suitable alternative
123 test group
124 therapy
125 tolerability
126 total
127 treatment
128 treatment groups
129 trials
130 two-sided confidence intervals
131 units
132 visits
133 weeks
134 weeks of treatment
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