Acute Aspirin Plus Cilostazol Dual Therapy for Noncardioembolic Stroke Patients Within 48 Hours of Symptom Onset. Issue 15 (6th August 2019)

• Record Type: Journal Article
• Authors: Aoki, Junya; Iguchi, Yasuyuki; Urabe, Takao; Yamagami, Hiroshi; Todo, Kenichi; Fujimoto, Shigeru; Idomari, Koji; Kaneko, Nobuyuki; Iwanaga, Takeshi; Terasaki, Tadashi; Tanaka, Ryota; Yamamoto, Nobuaki; Tsujino, Akira; Nomura, Koichi; Abe, Koji; Uno, Masaaki; Okada, Yasushi; Matsuoka, Hideki; Yamagata, Sen; Yamamoto, Yasumasa; Yonehara, Toshiro; Inoue, Takeshi; Yagita, Yoshiki; Kimura, Kazumi
• Other Names: Mitsumura Hidetaka investigator.; Ueno Yuji investigator.; Watanabe Masao investigator.; Sakamoto Yuki investigator.; Arakawa Shuji investigator.; Nagakane Yoshinari investigator.; Ishibashi Ryota investigator.; Terasawa Yuka investigator.; Fujita Koji investigator.; Kashihara Kenichi investigator.; Mitomi Mutsumi investigator.; Nakano Tatsu investigator.; Shibazaki Kensaku investigator.; Takao Yoshiki investigator.; Tateishi Yohei investigator.; Goto Seiji investigator.; Manabe Yasuhiro investigator.; Kanda Naoaki investigator.; Ohashi Toshihiko investigator.; Itabashi Ryo investigator.; Furui Eisuke investigator.; Takizawa Takaaki investigator.; Minami Masahiro investigator.; Noguchi Yasuhiro investigator.; Kondo Yoshiyuki investigator.; Izumi Tesseki investigator.; Sakima Hirokuni investigator.; Ueno Yasushi investigator.; Kasuya Junji investigator.; Oba Naoki investigator.
• Is Part Of: Journal of the American Heart Association. Volume 8:Issue 15(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-08-06
• Subjects: antiplatelet drug -- clinical trial -- ischemic stroke -- noncardioembolic stroke; Heart -- Diseases -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; Cerebrovascular disease -- Periodicals; Cardiology -- Periodicals; 616.1
• DOI: 10.1161/JAHA.119.012652
• Languages: English
• ISSNs: 2047-9980

Abstract

Abstract : 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, open‐label, 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 [61–77] 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. Clinical Trial Registration: URL: umin.ac.jp/ctr/index/htm. Unique identifier: UMIN000004950.