Clinical trial NCT00311402: JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Official title: JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 1295
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily


Eligibility criteria: Inclusion Criteria:

Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.

1. Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
2. Patients who are 50 years or older
3. Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
5. Patients who have at least two of the following risk factors:

   * diabetes
   * hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
   * smoker (at the time of onset of cerebral infarction)
   * obesity (Body mass index (BMI) is more than 25 kg/m2)
   * previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
   * end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
   * hyperlipidaemia

Exclusion Criteria:

1. Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
4. Patient with hypersensitivity to dipyridamole preparations
5. Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
6. Patients with a history of peptic ulcer
7. Patients having undergone arterial reconstruction after development of cerebral infarction
8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
11. Patients with complications such as serious cardiac, renal and hepatic disorders
12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years
13. Women who are or may be pregnant or lactating women

Primary outcomes:
measure: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
timeFrame: Up to 124 weeks
Secondary outcomes:
measure: Number of Patients With Brain (Cerebral) Haemorrhage
timeFrame: Up to 124 weeks
measure: Number of Patients With Subarachnoid Haemorrhage
timeFrame: Up to 124 weeks
measure: Number of Patients With Transient Ischemic Attack (TIA)
timeFrame: Up to 124 weeks
measure: Number of Patients With Acute Coronary Syndrome (ACS)
timeFrame: Up to 124 weeks
measure: Number of Patients With Other Vascular Events
timeFrame: Up to 124 weeks
measure: Number of Patients With Ischemic Vascular Event Composite Endpoint
timeFrame: Up to 124 weeks
Other outcomes:
Locations:
city: Adachi-ku, Tokyo
country: Japan
facility: 9.178.060 Boehringer Ingelheim Investigational Site
city: Adumino, Nagano
country: Japan
facility: 9.178.017 Boehringer Ingelheim Investigational Site
city: Akashi, Hyogo
country: Japan
facility: 9.178.032 Boehringer Ingelheim Investigational Site
city: Akashi, Hyogo
country: Japan
facility: 9.178.074 Boehringer Ingelheim Investigational Site
city: Ako, Hyogo
country: Japan
facility: 9.178.062 Boehringer Ingelheim Investigational Site
city: Aoba-ku, Yokohama, Kanagawa
country: Japan
facility: 9.178.064 Boehringer Ingelheim Investigational Site
city: Aoi-ku, Shizuoka, Shizuoka
country: Japan
facility: 9.178.097 Boehringer Ingelheim Investigational Site
city: Asahi, Chiba
country: Japan
facility: 9.178.056 Boehringer Ingelheim Investigational Site
city: Asahikawa, Hokkaido
country: Japan
facility: 9.178.067 Boehringer Ingelheim Investigational Site
city: Asahikawa, Hokkaido
country: Japan
facility: 9.178.117 Boehringer Ingelheim Investigational Site
city: Atsugi, Kanagawa
country: Japan
facility: 9.178.166 Boehringer Ingelheim Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: 9.178.089 Boehringer Ingelheim Investigational Site
city: Chitose, Hokkaido
country: Japan
facility: 9.178.054 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Chiba, Chiba
country: Japan
facility: 9.178.133 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Kobe, Hyogo
country: Japan
facility: 9.178.030 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Sapporo, Hokkaido
country: Japan
facility: 9.178.077 Boehringer Ingelheim Investigational Site
city: Chuo-Ku, Sappro, Hokkaido
country: Japan
facility: 9.178.002 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Sappro, Hokkaido
country: Japan
facility: 9.178.119 Boehringer Ingelheim Investigational Site
city: Daito, Osaka
country: Japan
facility: 9.178.161 Boehringer Ingelheim Investigational Site
city: Fuchu, Tokyo
country: Japan
facility: 9.178.112 Boehringer Ingelheim Investigational Site
city: Fujieda, Shizuoka
country: Japan
facility: 9.178.098 Boehringer Ingelheim Investigational Site
city: Fukaya, Saitama
country: Japan
facility: 9.178.046 Boehringer Ingelheim Investigational Site
city: Fukui, Fukui
country: Japan
facility: 9.178.145 Boehringer Ingelheim Investigational Site
city: Fukuroi, Shizuoka
country: Japan
facility: 9.178.099 Boehringer Ingelheim Investigational Site
city: Funabashi, Chiba
country: Japan
facility: 9.178.165 Boehringer Ingelheim Investigational Site
city: Fushimi-ku, Kyoto, Kyoto
country: Japan
facility: 9.178.072 Boehringer Ingelheim Investigational Site
city: Gifu, Gifu
country: Japan
facility: 9.178.081 Boehringer Ingelheim Investigational Site
city: Habikino, Osaka
country: Japan
facility: 9.178.024 Boehringer Ingelheim Investigational Site
city: Hachioji, Tokyo
country: Japan
facility: 9.178.136 Boehringer Ingelheim Investigational Site
city: Hakodate, Hokkaido
country: Japan
facility: 9.178.082 Boehringer Ingelheim Investigational Site
city: Hakodate, Hokkaido
country: Japan
facility: 9.178.118 Boehringer Ingelheim Investigational Site
city: Hamada, Shimane
country: Japan
facility: 9.178.052 Boehringer Ingelheim Investigational Site
city: Hashima-gun, Gifu
country: Japan
facility: 9.178.138 Boehringer Ingelheim Investigational Site
city: Hidaka, Saitama
country: Japan
facility: 9.178.169 Boehringer Ingelheim Investigational Site
city: Higashi-ku, Sappro, Hokkaido
country: Japan
facility: 9.178.001 Boehringer Ingelheim Investigational Site
city: Higashi-osaka, Osaka
country: Japan
facility: 9.178.026 Boehringer Ingelheim Investigational Site
city: Higashidakawa-gun, Yamagata
country: Japan
facility: 9.178.163 Boehringer Ingelheim Investigational Site
city: Higashimatsushima, Miyagi
country: Japan
facility: 9.178.120 Boehringer Ingelheim Investigational Site
city: Higashinari-ku, Osaka, Osaka
country: Japan
facility: 9.178.028 Boehringer Ingelheim Investigational Site
city: Higashiosaka, Osaka
country: Japan
facility: 9.178.140 Boehringer Ingelheim Investigational Site
city: Higashisonogi-gun, Nagasaki
country: Japan
facility: 9.178.122 Boehringer Ingelheim Investigational Site
city: Higashiyodogawa-ku, Osaka, Osaka
country: Japan
facility: 9.178.101 Boehringer Ingelheim Investigational Site
city: Himeji, Hyogo
country: Japan
facility: 9.178.093 Boehringer Ingelheim Investigational Site
city: Hitachi, Ibaraki
country: Japan
facility: 9.178.153 Boehringer Ingelheim Investigational Site
city: Hitachinaka, Ibaraki
country: Japan
facility: 9.178.005 Boehringer Ingelheim Investigational Site
city: Ibusuki, Kagoshima
country: Japan
facility: 9.178.079 Boehringer Ingelheim Investigational Site
city: Ichikawa, Chiba
country: Japan
facility: 9.178.143 Boehringer Ingelheim Investigational Site
city: Iida, Nagano
country: Japan
facility: 9.178.019 Boehringer Ingelheim Investigational Site
city: Inashiki-gun, Ibaraki
country: Japan
facility: 9.178.129 Boehringer Ingelheim Investigational Site
city: Isesaki, Gunma
country: Japan
facility: 9.178.011 Boehringer Ingelheim Investigational Site
city: Isesaki, Gunma
country: Japan
facility: 9.178.045 Boehringer Ingelheim Investigational Site
city: Itami, Hyogo
country: Japan
facility: 9.178.031 Boehringer Ingelheim Investigational Site
city: Iwanuma, Miyagi
country: Japan
facility: 9.178.135 Boehringer Ingelheim Investigational Site
city: Iwata, Shizuoka
country: Japan
facility: 9.178.104 Boehringer Ingelheim Investigational Site
city: Izuka, Fukuoka
country: Japan
facility: 9.178.095 Boehringer Ingelheim Investigational Site
city: Izumisano, Osaka
country: Japan
facility: 9.178.080 Boehringer Ingelheim Investigational Site
city: Izumo, Shimane
country: Japan
facility: 9.178.139 Boehringer Ingelheim Investigational Site
city: Izunokuni, Shizuoka
country: Japan
facility: 9.178.113 Boehringer Ingelheim Investigational Site
city: Kahoku-gun, Ishikawa
country: Japan
facility: 9.178.115 Boehringer Ingelheim Investigational Site
city: Kameda-gun, Hokkaido
country: Japan
facility: 9.178.147 Boehringer Ingelheim Investigational Site
city: Kamigyo-ku, Kyoto, Kyoto
country: Japan
facility: 9.178.092 Boehringer Ingelheim Investigational Site
city: Kasama, Ibaraki
country: Japan
facility: 9.178.008 Boehringer Ingelheim Investigational Site
city: Kasuga, Fukuoka
country: Japan
facility: 9.178.035 Boehringer Ingelheim Investigational Site
city: Kasuga, Fukuoka
country: Japan
facility: 9.178.037 Boehringer Ingelheim Investigational Site
city: Kawachinagano, Osaka
country: Japan
facility: 9.178.051 Boehringer Ingelheim Investigational Site
city: Kisarazu, Chiba
country: Japan
facility: 9.178.086 Boehringer Ingelheim Investigational Site
city: Kishiwada, Osaka
country: Japan
facility: 9.178.162 Boehringer Ingelheim Investigational Site
city: Kita-ku, Nagoya, Aichi
country: Japan
facility: 9.178.102 Boehringer Ingelheim Investigational Site
city: Kita-ku, Osaka, Osaka
country: Japan
facility: 9.178.023 Boehringer Ingelheim Investigational Site
city: Kita-ku, Osaka, Osaka
country: Japan
facility: 9.178.127 Boehringer Ingelheim Investigational Site
city: Kita-ku, Sappro, Hokkaido
country: Japan
facility: 9.178.004 Boehringer Ingelheim Investigational Site
city: Kitami, Hokkaido
country: Japan
facility: 9.178.154 Boehringer Ingelheim Investigational Site
city: Kitami, Hokkaido
country: Japan
facility: 9.178.155 Boehringer Ingelheim Investigational Site
city: Kiyose, Tokyo
country: Japan
facility: 9.178.069 Boehringer Ingelheim Investigational Site
city: Kiyose, Tokyo
country: Japan
facility: 9.178.070 Boehringer Ingelheim Investigational Site
city: Kochi, Kochi
country: Japan
facility: 9.178.121 Boehringer Ingelheim Investigational Site
city: Kochi, Kochi
country: Japan
facility: 9.178.141 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 9.178.061 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 9.178.085 Boehringer Ingelheim Investigational Site
city: Koshi, Kumamoto
country: Japan
facility: 9.178.075 Boehringer Ingelheim Investigational Site
city: Kurashiki, Okayama
country: Japan
facility: 9.178.107 Boehringer Ingelheim Investigational Site
city: Kushiro, Hokkaido
country: Japan
facility: 9.178.063 Boehringer Ingelheim Investigational Site
city: Kushiro, Hokkaido
country: Japan
facility: 9.178.083 Boehringer Ingelheim Investigational Site
city: Kushiro, Hokkaido
country: Japan
facility: 9.178.126 Boehringer Ingelheim Investigational Site
city: Marugame, Kagawa
country: Japan
facility: 9.178.150 Boehringer Ingelheim Investigational Site
city: Matsudo, Chiba
country: Japan
facility: 9.178.164 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 9.178.015 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 9.178.130 Boehringer Ingelheim Investigational Site
city: Meito-ku, Nagoya, Aichi
country: Japan
facility: 9.178.057 Boehringer Ingelheim Investigational Site
city: Midori-ku, Yokohama, Kanagawa
country: Japan
facility: 9.178.013 Boehringer Ingelheim Investigational Site
city: Minami-ku, Hiroshima, Hiroshima
country: Japan
facility: 9.178.043 Boehringer Ingelheim Investigational Site
city: Miyagino-ku, Sendai, Miyagi
country: Japan
facility: 9.178.068 Boehringer Ingelheim Investigational Site
city: Miyazaki, Miyazaki
country: Japan
facility: 9.178.116 Boehringer Ingelheim Investigational Site
city: Moriguchi, Osaka
country: Japan
facility: 9.178.142 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 9.178.078 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 9.178.084 Boehringer Ingelheim Investigational Site
city: Moriya, Ibaraki
country: Japan
facility: 9.178.009 Boehringer Ingelheim Investigational Site
city: Moriya, Ibaraki
country: Japan
facility: 9.178.149 Boehringer Ingelheim Investigational Site
city: Musashimurayama, Tokyo
country: Japan
facility: 9.178.071 Boehringer Ingelheim Investigational Site
city: Musashino, Tokyo
country: Japan
facility: 9.178.012 Boehringer Ingelheim Investigational Site
city: Naka-ku, Hamamatsu, Shizuoka
country: Japan
facility: 9.178.100 Boehringer Ingelheim Investigational Site
city: Naka-ku, Hamamatsu, Shizuoka
country: Japan
facility: 9.178.110 Boehringer Ingelheim Investigational Site
city: Naka-ku, Nagoya, Aichi
country: Japan
facility: 9.178.020 Boehringer Ingelheim Investigational Site
city: Nakagawa-ku, Nagoya, Aichi
country: Japan
facility: 9.178.053 Boehringer Ingelheim Investigational Site
city: Nakagawa-ku, Nagoya, Nagoya
country: Japan
facility: 9.178.132 Boehringer Ingelheim Investigational Site
city: Namegata, Ibaraki
country: Japan
facility: 9.178.124 Boehringer Ingelheim Investigational Site
city: Nanao, Ishikawa
country: Japan
facility: 9.178.158 Boehringer Ingelheim Investigational Site
city: Nishi-yodogawa-ku, Osaka, Osaka
country: Japan
facility: 9.178.029 Boehringer Ingelheim Investigational Site
city: Nishisonogi-gun, Nagasaki
country: Japan
facility: 9.178.096 Boehringer Ingelheim Investigational Site
city: Noda, Chiba
country: Japan
facility: 9.178.087 Boehringer Ingelheim Investigational Site
city: Obu, Aichi
country: Japan
facility: 9.178.058 Boehringer Ingelheim Investigational Site
city: Ohnojo, Fukuoka
country: Japan
facility: 9.178.034 Boehringer Ingelheim Investigational Site
city: Okayama, Okayama
country: Japan
facility: 9.178.157 Boehringer Ingelheim Investigational Site
city: Okinawa, Okinawa
country: Japan
facility: 9.178.167 Boehringer Ingelheim Investigational Site
city: Sagamihara, Kanagawa
country: Japan
facility: 9.178.137 Boehringer Ingelheim Investigational Site
city: Sakai, Osaka
country: Japan
facility: 9.178.027 Boehringer Ingelheim Investigational Site
city: Sakai, Osaka
country: Japan
facility: 9.178.073 Boehringer Ingelheim Investigational Site
city: Saku, Nagano
country: Japan
facility: 9.178.018 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 9.178.160 Boehringer Ingelheim Investigational Site
city: Setagaya-ku, Tokyo
country: Japan
facility: 9.178.041 Boehringer Ingelheim Investigational Site
city: Shibuya-ku, Tokyo
country: Japan
facility: 9.178.088 Boehringer Ingelheim Investigational Site
city: Shimogyo-ku, Kyoto, Kyoto
country: Japan
facility: 9.178.022 Boehringer Ingelheim Investigational Site
city: Shimotsuke, Tochigi
country: Japan
facility: 9.178.076 Boehringer Ingelheim Investigational Site
city: Shiroishi, Miyagi
country: Japan
facility: 9.178.055 Boehringer Ingelheim Investigational Site
city: Simizu-ku, Shizuoka, Shizuoka
country: Japan
facility: 9.178.111 Boehringer Ingelheim Investigational Site
city: Suminoe-ku, Osaka, Osaka
country: Japan
facility: 9.178.151 Boehringer Ingelheim Investigational Site
city: Susono, Shizuoka
country: Japan
facility: 9.178.156 Boehringer Ingelheim Investigational Site
city: Suwa, Nagano
country: Japan
facility: 9.178.014 Boehringer Ingelheim Investigational Site
city: Takasaki, Gunma
country: Japan
facility: 9.178.039 Boehringer Ingelheim Investigational Site
city: Takatsuki, Osaka
country: Japan
facility: 9.178.146 Boehringer Ingelheim Investigational Site
city: Takayama, Gifu
country: Japan
facility: 9.178.144 Boehringer Ingelheim Investigational Site
city: Takikawa, Hokkaido
country: Japan
facility: 9.178.003 Boehringer Ingelheim Investigational Site
city: Tatebayashi, Gunma
country: Japan
facility: 9.178.040 Boehringer Ingelheim Investigational Site
city: Teine-ku, Sapporo, Hokkaido
country: Japan
facility: 9.178.066 Boehringer Ingelheim Investigational Site
city: Tenri, Nara
country: Japan
facility: 9.178.134 Boehringer Ingelheim Investigational Site
city: Tonami, Toyama
country: Japan
facility: 9.178.159 Boehringer Ingelheim Investigational Site
city: Toride, Ibaraki
country: Japan
facility: 9.178.007 Boehringer Ingelheim Investigational Site
city: Toyama, Toyama
country: Japan
facility: 9.178.047 Boehringer Ingelheim Investigational Site
city: Toyohashi, Aichi
country: Japan
facility: 9.178.090 Boehringer Ingelheim Investigational Site
city: Toyota, Aichi
country: Japan
facility: 9.178.131 Boehringer Ingelheim Investigational Site
city: Tsuchiura, Ibaraki
country: Japan
facility: 9.178.006 Boehringer Ingelheim Investigational Site
city: Ueda, Nagano
country: Japan
facility: 9.178.016 Boehringer Ingelheim Investigational Site
city: Uji, Kyoto
country: Japan
facility: 9.178.091 Boehringer Ingelheim Investigational Site
city: Ukyo-ku, Kyoto, Kyoto
country: Japan
facility: 9.178.050 Boehringer Ingelheim Investigational Site
city: Urayasu, Chiba
country: Japan
facility: 9.178.106 Boehringer Ingelheim Investigational Site
city: Wakayama, Wakayama
country: Japan
facility: 9.178.148 Boehringer Ingelheim Investigational Site
city: Wko, Saitama
country: Japan
facility: 9.178.114 Boehringer Ingelheim Investigational Site
city: Yaizu, Shizuoka
country: Japan
facility: 9.178.152 Boehringer Ingelheim Investigational Site
city: Yamashina, Kyoto, Kyoto
country: Japan
facility: 9.178.125 Boehringer Ingelheim Investigational Site
city: Yanai, Yamaguchi
country: Japan
facility: 9.178.108 Boehringer Ingelheim Investigational Site
city: Yao, Osaka
country: Japan
facility: 9.178.103 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.