著者
Masatsugu Hori Masayasu Matsumoto Norio Tanahashi Shin-ichi Momomura Shinichiro Uchiyama Shinya Goto Tohru Izumi Yukihiro Koretsune Mariko Kajikawa Masaharu Kato Hitoshi Ueda Kazuya Iwamoto Masahiro Tajiri on behalf of the J-ROCKET AF study investigators
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-12-0454, (Released:2012-06-05)
参考文献数
13
被引用文献数
164 511

Background: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. Methods and Results: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87–1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). Conclusions: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice.
著者
Mari Matsumoto Manabu Sakaguchi Shuhei Okazaki Kazuo Hashikawa Tsutomu Takahashi Masayasu Matsumoto Toshiho Ohtsuki Takeshi Shimazu Toshiki Yoshimine Hideki Mochizuki Kazuo Kitagawa
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-16-0707, (Released:2017-01-31)
参考文献数
18
被引用文献数
1 7

Background:In Japan, warfarin treatment at prothrombin time-international normalized ratio (PT-INR) of 1.60–2.60 is recommended for elderly patients with nonvalvular atrial fibrillation (NVAF). But it remains unknown whether PT-INR 1.60–1.99 has a similar effect on stroke severity as a value >2.0. The purpose of this study was to clarify the association between infarct volume and PT-INR levels.Methods and Results:The 180 patients (mean age, 76 years [SD, 10 years], 53% male) selected from 429 consecutive ischemic stroke patients admitted within 48 h of onset between 2004 and 2014 with NVAF were included. We classified them into 4 groups according to their PT-INR values on admission: no warfarin (NW), 129 patients; PT-INR <1.60 (poor control: PC), 29 patients; PT-INR 1.60–1.99 (low-intensity control: LC), 14 patients; and PT-INR ≥2.00 (high-intensity control: HC), 8 patients. Median (interquartile range: IQR) of infarct volume was 55 mL (IQR 14–175) in the NW, 42 mL (IQR 27–170) in the PC, 36 mL (IQR 6–130) in the LC, and 11 mL (IQR 0–39) in the HC groups. The infarct volume of the HC group was significantly smaller than in the other 3 groups, but no difference existed between the LC and PC groups or the LC and NW groups.Conclusions:Warfarin control at PT-INR of 1.60–1.99 is not effective for reducing the severity of ischemic stroke in NVAF patients.
著者
Masatsugu Hori Masayasu Matsumoto Norio Tanahashi Shin-ichi Momomura Shinichiro Uchiyama Shinya Goto Tohru Izumi Yukihiro Koretsune Mariko Kajikawa Masaharu Kato Hitoshi Ueda Kazuya Iwamoto Masahiro Tajiri on behalf of the J-ROCKET AF study investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.76, no.9, pp.2104-2111, 2012 (Released:2012-08-24)
参考文献数
13
被引用文献数
304 511

Background: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. Methods and Results: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87–1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). Conclusions: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice.  (Circ J 2012; 76: 2104–2111)
著者
Takanari Kitazono Kazunori Toyoda Kazuo Kitagawa Takehiko Nagao Hiroshi Yamagami Shinichiro Uchiyama Norio Tanahashi Masayasu Matsumoto Kazuo Minematsu Izumi Nagata Masakatsu Nishikawa Shinsuke Nanto Yasuo Ikeda Toshiaki Shirai Kenji Abe Akira Ogawa PRASTRO-I Study Group
出版者
Japan Atherosclerosis Society
雑誌
Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日
pp.56093, (Released:2020-06-04)
参考文献数
19
被引用文献数
10

Aims: The efficacy of antiplatelet therapy may vary among different disease subtypes. Prasugrel is generally a more potent, consistent, and fast-acting platelet inhibitor than clopidogrel. This sub-analysis of the phase III comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO-I) trial aimed to assess the differences in efficacy of these treatments for each stroke subtype. Methods: In the PRASTRO-I trial, a total of 3,753 patients with ischemic stroke were recruited from 224 centers throughout Japan and randomized (1:1) to prasugrel (3.75 mg/day) or clopidogrel (75 mg/day) for 96 weeks. For the sub-analysis, strokes were classified as large-artery atherosclerosis, small-artery occlusion (lacunar), stroke of other etiology, and stroke of undetermined etiology. The cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs) were calculated for each subgroup. Results: For patients with large-artery atherosclerosis, the primary event incidence was 3.8% in the prasugrel group and 4.8% in the clopidogrel group (HR 0.79; 95% confidence interval [CI] 0.45–1.40). For patients with small-artery occlusion, the incidence was 3.3% in the prasugrel group and 3.9% in the clopidogrel group (HR 0.83; 95% CI 0.46–1.53). For patients with stroke of undetermined etiology, the incidence was 4.6% in the prasugrel group and 3.0% in the clopidogrel group (HR 1.56; 95% CI 0.90–2.72). The incidence of bleeding was similar across subtypes. Conclusions: Although statistical significance was not reached, the efficacy of prasugrel was potentially different between stroke subtypes, warranting further studies.
著者
Kazuo Kitagawa Naohisa Hosomi Yoji Nagai Tatsuo Kagimura Toshiho Ohtsuki Hirofumi Maruyama Hideki Origasa Kazuo Minematsu Shinichiro Uchiyama Masakazu Nakamura Masayasu Matsumoto for the J-STARS collaborators
出版者
Japan Atherosclerosis Society
雑誌
Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日
vol.26, no.5, pp.432-441, 2019-05-01 (Released:2019-05-01)
参考文献数
18
被引用文献数
17 24

Aims: To investigate the relative contribution of on-treatment low-density lipoprotein (LDL) cholesterol and C-reactive protein (CRP) to the risk of recurrent stroke and transient ischemic attack (TIA) in patients with history of ischemic stroke.Methods: A total of 1095 patients with non-cardioembolic ischemic stroke were randomized into two groups: control and patients receiving 10 mg of pravastatin per day. After excluding 18 patients who did not have baseline CRP data, the effects of LDL cholesterol and CRP on recurrent stroke and TIA were prospectively assessed in 1077 patients.Results: During the follow-up of 4.9±1.4 years, there were 131 recurrent stroke or TIA cases. Patients with ontreatment LDL cholesterol <120 mg/dL showed 29% reduction in recurrent stroke and TIA than those with LDL cholesterol ≥ 120 mg/dL (event rate 2.20 vs. 3.11 per 100 person-years, hazard ratio [HR] 0.71, 95% confidence interval (CI) 0.50–0.99, p=0.048). Patients with CRP <1 mg/L had 32% reduction compared with that of patients with CRP ≥ 1 mg/L (event rate 2.26 vs. 3.40 per 100 person-years; HR 0.68, 95% CI 0.48–0.96, p=0.031). Although LDL cholesterol and CRP levels were not correlated in individual patients, those who achieved both LDL cholesterol <120 mg/dL and CRP <1 mg/L showed 51% reduction compared with that of patients with LDL cholesterol ≥ 120 mg/dL and CRP ≥ 1 mg/L (event rate 2.02 vs. 4.19 per 100 person-years; HR 0.49, 95% CI 0.31–0.79).Conclusions: The control of both LDL cholesterol and CRP levels appears to be effective for preventing recurrent stroke and TIA in patients with non-cardiogenic ischemic stroke.
著者
Isha Shrestha Toshiho Ohtsuki Tetsuya Takahashi Eiichi Nomura Tatsuo Kohriyama Masayasu Matsumoto
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.73, no.10, pp.1945-1949, 2009 (Released:2009-09-25)
参考文献数
29
被引用文献数
10 28

Background: The diagonal ear-lobe crease (ELC) is reported to be a marker of cardiovascular disease. Very few reports have assessed the relationship of ELC with atherosclerosis. This relationship is investigated here using a Japanese population. Methods and Results: A prospective cross-sectional study included 212 consecutive patients. Bilateral ear lobes were checked for the ELC and this was followed by carotid ultrasonography to measure the far wall common carotid artery intima-media thickness (CCA-IMT), plaque score (PS) and plaque number (PN). Patients with ELC had significantly higher carotid IMT than controls (0.90 ±0.24 vs 0.77 ±0.15, respectively, P<0.001). ELC presence correlated significantly with carotid IMT, PS, and PN (r=0.306, P<0.0001; r=0.198, P<0.008 and r=0.221, P<0.0001, respectively), and also with age, male sex and hypertension. ELC presence and absence in mild or no PS and moderate or severe PS subgroups was significant, with a chi-squared value of 7.59 (P<0.006). In multivariate regression analysis, ELC presence correlated with CCA-IMT independently. The odds ratio for the presence of ELC in patients with CCA-IMT of <0.8 mm vs patients with CCA-IMT of ≥0.8 mm (the median value) was 0.41 (95% confidence interval, 0.22-0.76). Conclusions: The present study showed an association between ELC and increased CCA-IMT, PS, and PN. (Circ J 2009; 73: 1945-1949)