Acute Aspirin Plus Cilostazol Dual Therapy for Noncardioembolic Stroke Patients Within 48 Hours of Symptom Onset

被引：35

作者：

Aoki, Junya ^{[1
,2
]}

Iguchi, Yasuyuki ^{[5
]}

Urabe, Takao ^{[6
]}

Yamagami, Hiroshi ^{[7
]}

Todo, Kenichi ^{[7
]}

Fujimoto, Shigeru ^{[8
]}

Idomari, Koji ^{[9
]}

Kaneko, Nobuyuki ^{[9
]}

Iwanaga, Takeshi ^{[10
]}

Terasaki, Tadashi ^{[11
]}

Tanaka, Ryota ^{[12
]}

Yamamoto, Nobuaki ^{[13
]}

Tsujino, Akira ^{[14
]}

Nomura, Koichi ^{[15
]}

Abe, Koji ^{[16
]}

Uno, Masaaki ^{[3
]}

Okada, Yasushi ^{[17
]}

Matsuoka, Hideki ^{[18
]}

Yamagata, Sen ^{[19
]}

Yamamoto, Yasumasa ^{[20
]}

Yonehara, Toshiro ^{[21
]}

Inoue, Takeshi ^{[4
,10
]}

Yagita, Yoshiki ^{[2
]}

Kimura, Kazumi ^{[1
,2
]}

Mitsumura, Hidetaka ^{[22
]}

Ueno, Yuji ^{[23
]}

Watanabe, Masao ^{[24
]}

Sakamoto, Yuki ^{[25
]}

Arakawa, Shuji ^{[26
]}

Nagakane, Yoshinari ^{[27
]}

Ishibashi, Ryota ^{[28
]}

Terasawa, Yuka ^{[29
]}

Fujita, Koji ^{[29
]}

Kashihara, Kenichi ^{[30
]}

Mitomi, Mutsumi ^{[31
]}

Nakano, Tatsu ^{[31
]}

Shibazaki, Kensaku ^{[32
]}

Takao, Oshiki ^{[32
]}

Tateishi, Yohei ^{[33
]}

Goto, Seiji ^{[34
]}

Manabe, Yasuhiro ^{[35
]}

Kanda, Naoaki ^{[36
]}

Ohashi, Toshihiko ^{[37
]}

Okada, Yoko ^{[38
]}

Itabashi, Ryo ^{[39
]}

Furui, Eisuke ^{[39
]}

Takizawa, Takaaki ^{[40
]}

Minami, Masahiro ^{[40
]}

Noguchi, Yasuhiro ^{[40
]}

Kondo, Yoshiyuki ^{[41
]}

机构：

[1] Nippon Med Sch, Grad Sch Med, Dept Neurol Sci, Tokyo, Japan

[2] Kawasaki Med Sch, Dept Stroke Med, Okayama, Japan

[3] Kawasaki Med Sch, Dept Neurosurg, Okayama, Japan

[4] Kawasaki Med Sch, Gen Med Ctr, Okayama, Japan

[5] Jikei Univ, Dept Neurol, Sch Med, Tokyo, Japan

[6] Juntendo Univ, Dept Neurol, Urayasu Hosp, Chiba, Japan

[7] Kobe City Med Ctr Gen Hosp, Stroke Ctr, Dept Neurol, Kobe, Hyogo, Japan

[8] Steel Mem Yawata Hosp, Stroke Ctr, Dept Cerebrovasc Med, Fukuoka, Fukuoka, Japan

[9] Okinawa Kyodo Hosp, Dept Stroke Med, Naha, Okinawa, Japan

[10] Okayama Red Cross Hosp, Dept Stroke Med, Okayama, Japan

[11] Japanese Red Cross Kumamoto Hosp, Dept Neurol, Kumamoto, Japan

[12] Juntendo Univ, Fac Med, Dept Neurol, Tokyo, Japan

[13] Tokushima Univ, Inst Biomed Sci, Dept Clin Neurosci, Tokushima, Japan

[14] Nagasaki Univ Hosp, Dept Neurol & Strokol, Nagasaki, Japan

[15] Shioda Hosp, Dept Neurol, Chiba, Japan

[16] Okayama Univ, Dept Neurol, Med Sch, Okayama, Japan

[17] Natl Hosp Org, Kyushu Med Ctr, Clin Res Inst, Dept Cerebrovasc Med & Neurol, Fukuoka, Fukuoka, Japan

[18] NHO Kagoshima Med Ctr, Dept Cerebrovasc Med, Kagoshima, Japan

[19] Kurashiki Cent Hosp, Dept Neurosurg, Okayama, Japan

[20] Kyoto Second Red Cross Hosp, Dept Neurol, Kyoto, Japan

[21] Saiseikai Kumamoto Hosp, Stroke Ctr, Dept Neurol, Kumamoto, Japan

[22] Jikei Univ, Sch Med, Tokyo, Japan

[23] Juntendo Univ, Sch Med, Chiba, Japan

[24] Juntendo Univ, Urayasu Hosp, Chiba, Japan

[25] Nippon Med Sch, Tokyo, Japan

[26] Steel Mem Yawata Hosp, Kitakyushu, Fukuoka, Japan

[27] Kyoto Second Red Cross Hosp, Kyoto, Japan

[28] Kurashiki Cent Hosp, Kurashiki, Okayama, Japan

[29] Tokushima Univ, Tokushima, Japan

[30] Okayama Kyokuto Hosp, Okayama, Japan

[31] Yokohama Sakae Kyosai Hosp, Yokohama, Kanagawa, Japan

[32] Kurashiki Heisei Hosp, Kurashiki, Okayama, Japan

[33] Nagasaki Univ, Nagasaki, Japan

[34] Kyushu Med Ctr, Fukuoka, Fukuoka, Japan

[35] Okayama Med Ctr, Okayama, Japan

[36] Imamura Gen Hosp, Kagoshima, Japan

[37] Seirei Hamamatsu Gen Hosp, Hamamatsu, Shizuoka, Japan

[38] Ehime Univ, Grad Sch Med, Matsuyama, Ehime, Japan

[39] Kohnan Hosp, Sendai, Miyagi, Japan

[40] Okayama Tobu Noshinkeigeka Hosp, Okayama, Japan

[41] Seirei Mikatahara Gen Hosp, Hamamatsu, Shizuoka, Japan

[42] Nara Med Univ, Nara, Japan

[43] Univ Ryukyus, Nishihara, Okinawa, Japan

[44] Shinko Hosp, Kobe, Hyogo, Japan

[45] Atsuchi Neurosurg Hosp, Saito, Japan

[46] Heisei Mem Hosp, Toyonaka, Osaka, Japan

来源：

JOURNAL OF THE AMERICAN HEART ASSOCIATION | 2019年 / 8卷 / 15期

关键词：

antiplatelet drug; clinical trial; ischemic stroke; noncardioembolic stroke; ACUTE ISCHEMIC-STROKE; OPEN-LABEL; TRIAL; CLOPIDOGREL; PREVENTION; STENOSIS;

D O I：

10.1161/JAHA.119.012652

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background-The aim of the present study was to investigate the efficacy and safety of antiplatelet (aspirin plus cilostazol) dual therapy for patients with noncardioembolic stroke within 48 hours of symptom onset. Methods and Results-The ADS (Acute Aspirin Plus Cilostazol Dual Therapy for Non-Cardiogenic Stroke Patients Within 48 Hours of Symptom Onset) study is an investigator-initiated, prospective, multicenter (34 hospitals in Japan), randomized, openlabel, and aspirin-controlled trial. Acute stroke patients with noncardioembolic stroke within 48 hours of onset were studied. The subjects were randomly allocated to combination therapy with aspirin 81 to 200 mg plus cilostazol 200 mg (dual group) and single therapy with aspirin 81 to 200 mg (aspirin group) for 14 days. After the 14 days, all patients took the cilostazol 200 mg for 3 months. A primary efficacy outcome was defined as any one of the following occurring (neurological deterioration, symptomatic stroke recurrence, or transient ischemic attack) within 14 days. A primary safety outcome included intracerebral hemorrhage and subarachnoid hemorrhage. Between May 2011 and June 2017, 1201 patients (796 [66%] men; median age, 69 [61-771 years) randomized 1:1 to either the dual group or the aspirin group were analyzed. Initial National Institutes of Health Stroke Scale score was 2 (1-4) in both groups (P=0.830). A primary efficacy outcome was observed in 11% in the dual group and 11% in the aspirin group (P=0.853). A primary safety outcome occurred in 2 (0.3%) in the dual group and in 1 (0.2%) in the aspirin group (P=0.624). Conclusions-Dual antiplatelet therapy using cilostazol and aspirin was safe but did not reduce the rate of short-term neurological worsening.

引用

页数：23

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