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Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting
Background and Purpose: Patients undergoing carotid artery stenting (CAS) who show low responsiveness to clopidogrel may have a higher risk of peri-procedural embolic events. This study aimed to compare the effectiveness and safety of clopidogrel and ticlopidine plus Ginkgo biloba in clopidogrel-res...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6363652/ https://www.ncbi.nlm.nih.gov/pubmed/30761076 http://dx.doi.org/10.3389/fneur.2019.00044 |
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author | Chung, Jong-Won Kim, Suk Jae Hwang, Jaechun Lee, Mi Ji Lee, Jun Lee, Kyung-Yul Park, Man-Seok Sung, Sang Min Kim, Keon Ha Jeon, Pyoung Bang, Oh Young |
author_facet | Chung, Jong-Won Kim, Suk Jae Hwang, Jaechun Lee, Mi Ji Lee, Jun Lee, Kyung-Yul Park, Man-Seok Sung, Sang Min Kim, Keon Ha Jeon, Pyoung Bang, Oh Young |
author_sort | Chung, Jong-Won |
collection | PubMed |
description | Background and Purpose: Patients undergoing carotid artery stenting (CAS) who show low responsiveness to clopidogrel may have a higher risk of peri-procedural embolic events. This study aimed to compare the effectiveness and safety of clopidogrel and ticlopidine plus Ginkgo biloba in clopidogrel-resistant patients undergoing CAS. Methods: In this multi-center, randomized, controlled trial, we used platelet reactivity test to select patients undergoing CAS who showed clopidogrel resistance, and compared treatments using clopidogrel and ticlopidine plus ginkgo. The primary outcome was the incidence of new ischemic lesion in the ipsilateral hemisphere of CAS. Detection of microembolic signal on transcranial Doppler was the secondary outcome. The clinical outcomes were also monitored. Results: This trial was discontinued after 42 patients were randomized after preplanned interim sample size re-estimation indicated an impractical sample size. The primary endpoint occurred in 12/22 patients (54.5%) in the clopidogrel group and 13/20 patients (65.0%) in the ticlopidine–ginkgo group (P = 0.610). No significant differences in the presence of microembolic signal (15.0 vs. 11.8%, P = 0.580), clinical outcomes (ischemic stroke or transient ischemic attack, 0.0 vs. 5.5%; acute myocardial infarction 0.0 vs. 0.0%; all-cause death, 4.5 vs. 0.0%), or incidence of adverse events were found in the two groups. In terms of resistance to clopidogrel, treatment with ticlopidine–ginkgo significantly increased the P2Y12 Reaction Units (difference, 0.0 [−0.3–3.0] vs. 21.0 [6.0–35.0], P < 0.001). Conclusions: In patients who showed clopidogrel resistance, ticlopidine–ginkgo treatment was safe and increased P2Y12 Reaction Units; however, compared to clopidogrel, it failed to improve surrogate and clinical endpoints in patients undergoing CAS. This multimodal biomarker-based clinical trial is feasible in neurointerventional research. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02133989. |
format | Online Article Text |
id | pubmed-6363652 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-63636522019-02-13 Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting Chung, Jong-Won Kim, Suk Jae Hwang, Jaechun Lee, Mi Ji Lee, Jun Lee, Kyung-Yul Park, Man-Seok Sung, Sang Min Kim, Keon Ha Jeon, Pyoung Bang, Oh Young Front Neurol Neurology Background and Purpose: Patients undergoing carotid artery stenting (CAS) who show low responsiveness to clopidogrel may have a higher risk of peri-procedural embolic events. This study aimed to compare the effectiveness and safety of clopidogrel and ticlopidine plus Ginkgo biloba in clopidogrel-resistant patients undergoing CAS. Methods: In this multi-center, randomized, controlled trial, we used platelet reactivity test to select patients undergoing CAS who showed clopidogrel resistance, and compared treatments using clopidogrel and ticlopidine plus ginkgo. The primary outcome was the incidence of new ischemic lesion in the ipsilateral hemisphere of CAS. Detection of microembolic signal on transcranial Doppler was the secondary outcome. The clinical outcomes were also monitored. Results: This trial was discontinued after 42 patients were randomized after preplanned interim sample size re-estimation indicated an impractical sample size. The primary endpoint occurred in 12/22 patients (54.5%) in the clopidogrel group and 13/20 patients (65.0%) in the ticlopidine–ginkgo group (P = 0.610). No significant differences in the presence of microembolic signal (15.0 vs. 11.8%, P = 0.580), clinical outcomes (ischemic stroke or transient ischemic attack, 0.0 vs. 5.5%; acute myocardial infarction 0.0 vs. 0.0%; all-cause death, 4.5 vs. 0.0%), or incidence of adverse events were found in the two groups. In terms of resistance to clopidogrel, treatment with ticlopidine–ginkgo significantly increased the P2Y12 Reaction Units (difference, 0.0 [−0.3–3.0] vs. 21.0 [6.0–35.0], P < 0.001). Conclusions: In patients who showed clopidogrel resistance, ticlopidine–ginkgo treatment was safe and increased P2Y12 Reaction Units; however, compared to clopidogrel, it failed to improve surrogate and clinical endpoints in patients undergoing CAS. This multimodal biomarker-based clinical trial is feasible in neurointerventional research. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02133989. Frontiers Media S.A. 2019-01-30 /pmc/articles/PMC6363652/ /pubmed/30761076 http://dx.doi.org/10.3389/fneur.2019.00044 Text en Copyright © 2019 Chung, Kim, Hwang, Lee, Lee, Lee, Park, Sung, Kim, Jeon and Bang. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Neurology Chung, Jong-Won Kim, Suk Jae Hwang, Jaechun Lee, Mi Ji Lee, Jun Lee, Kyung-Yul Park, Man-Seok Sung, Sang Min Kim, Keon Ha Jeon, Pyoung Bang, Oh Young Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title | Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title_full | Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title_fullStr | Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title_full_unstemmed | Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title_short | Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting |
title_sort | comparison of clopidogrel and ticlopidine/ginkgo biloba in patients with clopidogrel resistance and carotid stenting |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6363652/ https://www.ncbi.nlm.nih.gov/pubmed/30761076 http://dx.doi.org/10.3389/fneur.2019.00044 |
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