Effect of ticagrelor with clopidogrel on high on-treatment platelet reactivity in acute stroke or transient ischemic attack (PRINCE) trial: Rationale and design

被引：12

作者：

Wang, Yilong ^{[1
,2
,3
,4
]}

Lin, Yi ^{[5
,6
]}

Meng, Xia ^{[1
,2
,3
,4
]}

Chen, Weiqi ^{[1
,2
,3
,4
]}

Chen, Guohua ^{[7
]}

Wang, Zhimin ^{[8
]}

Wu, Jialing ^{[9
]}

Wang, Dali ^{[10
]}

Li, Jianhua ^{[11
]}

Cao, Yibin ^{[12
]}

Xu, Yuming ^{[13
]}

Zhang, Guohua ^{[14
]}

Li, Xiaobo ^{[15
]}

Pan, Yuesong ^{[1
,2
,3
,4
]}

Li, Hao ^{[1
,2
,3
,4
]}

Liu, Liping ^{[1
,2
,3
,4
]}

Zhao, Xingquan ^{[1
,2
,3
,4
]}

Wang, Yongjun ^{[1
,2
,3
,4
]}

机构：

[1] Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, 6 Tiantanxili, Beijing 100050, Peoples R China

[2] China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China

[3] Beijing Inst Brain Disorders, Ctr Stroke, Beijing, Peoples R China

[4] Beijing Key Lab Translat Med Cerebrovasc Dis, Beijing, Peoples R China

[5] Fujian Med Univ, Affiliated Hosp 1, Dept Neurol, Fuzhou, Peoples R China

[6] Fujian Med Univ, Affiliated Hosp 1, Inst Neurol, Fuzhou, Peoples R China

[7] Wuhan 1 Hosp, Dept Neurol, Wuhan, Peoples R China

[8] Wenzhou Med Univ, Huangyan Hosp, Taizhou Peoples Hosp 1, Dept Neurol, Taizhou, Peoples R China

[9] Tianjin Huanhu Hosp, Dept Neurol, Tianjin, Peoples R China

[10] North China Univ Sci & Technol, Affiliated Hosp, Dept Neurol, Tangshan, Peoples R China

[11] First Hosp Fangshan Dist, Dept Neurol, Beijing, Peoples R China

[12] Tangshan Gongren Hosp, Dept Neurol, Tangshan, Peoples R China

[13] Zhengzhou Univ, Affiliated Hosp 1, Dept Neurol, Zhengzhou, Peoples R China

[14] Hebei Med Univ, Hosp 2, Dept Neurol, Shijiazhuang, Peoples R China

[15] Yangzhou Univ, Sch Clin Med, Northern Jiangsu Peoples Hosp, Dept Neurol, Yangzhou, Jiangsu, Peoples R China

来源：

INTERNATIONAL JOURNAL OF STROKE | 2017年 / 12卷 / 03期

基金：

中国国家自然科学基金;

关键词：

Clopidogrel; minor stroke; platelet reactivity; protocol; transient ischemic attack; ticagrelor; ACUTE CORONARY SYNDROMES; SHORT-TERM PROGNOSIS; MINOR STROKE; CYP2C19; IMPLANTATION; OUTCOMES; RISK;

D O I：

10.1177/1747493017694390

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Rationale and aim Little is known about the safety and efficacy of the combination of ticagrelor and aspirin in acute ischemic stroke. This study aimed to evaluate whether the combination of ticagrelor and aspirin was superior to that of clopidogrel and aspirin in reducing the 90-day high on-treatment platelet reactivity for acute minor stroke or transient ischemic attack, especially for carriers of cytochrome P450 2C19 loss-of-function allele. Sample size and design This study was designed as a prospective, multicenter, randomized, open-label, active-controlled, and blind-endpoint, phase II b trial. The required sample size was 952 patients. It was registered with ClinicalTrials.gov (NCT02506140). Study outcomes The primary outcome was the proportion of patients with high on-treatment platelet reactivity at 90 days. High on-treatment platelet reactivity is defined as the P2Y12 reaction unit >208 measured using the VerifyNow P2Y12 assay. Conclusion The Platelet Reactivity in Acute Non-disabling Cerebrovascular Events study explored whether ticagrelor combined with aspirin could reduce further the proportion of patients with high on-treatment platelet reactivity at 90 days after acute minor stroke or transient ischemic attack compared with clopidogrel and aspirin.

引用

页码：321 / 325

页数：5

共 14 条

[1] One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke [J].

Amarenco, Pierre ;

Lavallee, Philippa C. ;

Labreuche, Julien ;

Albers, Gregory W. ;

Bornstein, Natan M. ;

Canhao, Patricia ;

Caplan, Louis R. ;

Donnan, Geoffrey A. ;

Ferro, Jose M. ;

Hennerici, Michael G. ;

Molina, Carlos ;

Rothwell, Peter M. ;

Sissani, Leila ;

Skoloudik, David ;

Steg, Philippe Gabriel ;

Touboul, Pierre-Jean ;

Uchiyama, Shinichiro ;

Vicaut, Eric ;

Wong, Lawrence K. S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 374 (16) :1533-1542

[2] Medical Management After Coronary Stent Implantation A Review [J].

Brilakis, Emmanouil S. ;

Patel, Vishal G. ;

Banerjee, Subhash .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (02) :189-198

[3] Short-term prognosis after emergency department diagnosis of TIA [J].

Johnston, SC ;

Gress, DR ;

Browner, WS ;

Sidney, S .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 284 (22) :2901-2906

[4] Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association [J].

Kernan, Walter N. ;

Ovbiagele, Bruce ;

Black, Henry R. ;

Bravata, Dawn M. ;

Chimowitz, Marc I. ;

Ezekowitz, Michael D. ;

Fang, Margaret C. ;

Fisher, Marc ;

Furie, Karen L. ;

Heck, Donald V. ;

Johnston, S. Claiborne ;

Kasner, Scott E. ;

Kittner, Steven J. ;

Mitchell, Pamela H. ;

Rich, Michael W. ;

Richardson, DeJuran ;

Schwamm, Lee H. ;

Wilson, John A. .

STROKE, 2014, 45 (07) :2160-2236

[5] Incidence and short-term prognosis of transient ischemic attack in a population-based study [J].

Kleindorfer, D ;

Panagos, P ;

Pancioli, A ;

Khoury, J ;

Kissela, B ;

Woo, D ;

Schneider, A ;

Alwell, K ;

Jauch, E ;

Miller, R ;

Moomaw, C ;

Shukla, R ;

Broderick, JP .

STROKE, 2005, 36 (04) :720-723

[6] Platelet reactivity in the early and late phases of acute coronary syndromes according to cytochrome P450 2C19 phenotypes [J].

Nagashima, Zenko ;

Tsukahara, Kengo ;

Morita, Satoshi ;

Endo, Tsutomu ;

Sugano, Teruyasu ;

Hibi, Kiyoshi ;

Himeno, Hideo ;

Fukui, Kazuki ;

Umemura, Satoshi ;

Kimura, Kazuo .

JOURNAL OF CARDIOLOGY, 2013, 62 (3-4) :158-164

[7] Clinical Pharmacogenetics Implementation Consortium Guidelines for Cytochrome P450-2C19 (CYP2C19) Genotype and Clopidogrel Therapy [J].

Scott, S. A. ;

Sangkuhl, K. ;

Gardner, E. E. ;

Stein, C. M. ;

Hulot, J-S ;

Johnson, J. A. ;

Roden, D. M. ;

Klein, T. E. ;

Shuldiner, A. R. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2011, 90 (02) :328-332

[8] Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): a prospective multicentre registry study [J].

Stone, Gregg W. ;

Witzenbichler, Bernhard ;

Weisz, Giora ;

Rinaldi, Michael J. ;

Neumann, Franz-Josef ;

Metzger, D. Christopher ;

Henry, Timothy D. ;

Cox, David A. ;

Duffy, Peter L. ;

Mazzaferri, Ernest ;

Gurbel, Paul A. ;

Xu, Ke ;

Parise, Helen ;

Kirtane, Ajay J. ;

Brodie, Bruce R. ;

Mehran, Roxana ;

Stuckey, Thomas D. .

LANCET, 2013, 382 (9892) :614-623

[9] Consensus and Update on the Definition of On-Treatment Platelet Reactivity to Adenosine Diphosphate Associated With Ischemia and Bleeding [J].

Tantry, Udaya S. ;

Bonello, Laurent ;

Aradi, Daniel ;

Price, Matthew J. ;

Jeong, Young-Hoon ;

Angiolillo, Dominick J. ;

Stone, Gregg W. ;

Curzen, Nick ;

Geisler, Tobias ;

ten Berg, Jurrien ;

Kirtane, Ajay ;

Siller-Matula, Jolanta ;

Mahla, Elisabeth ;

Becker, Richard C. ;

Bhatt, Deepak L. ;

Waksman, Ron ;

Rao, Sunil V. ;

Alexopoulos, Dimitrios ;

Marcucci, Rossella ;

Reny, Jean-Luc ;

Trenk, Dietmar ;

Sibbing, Dirk ;

Gurbel, Paul A. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 62 (24) :2261-2273

[10] Effect of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes: a genetic substudy of the PLATO trial [J].

Wallentin, Lars ;

James, Stefan ;

Storey, Robert F. ;

Armstrong, Martin ;

Barratt, Bryan J. ;

Horrow, Jay ;

Husted, Steen ;

Katus, Hugo ;

Steg, P. Gabriel ;

Shah, Svati H. ;

Becker, Richard C. .

LANCET, 2010, 376 (9749) :1320-1328

← 1 2 →