Cerebrovascular Accident Clinical Trial
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
| NCT number | NCT00311402 |
| Other study ID # | 9.178 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | March 28, 2006 |
| Last updated | January 21, 2014 |
| Start date | April 2006 |
| Verified date | January 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1295 |
| Est. completion date | |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 |
Intervention Model: Parallel Assignment, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Japan | 9.178.060 Boehringer Ingelheim Investigational Site | Adachi-ku, Tokyo | |
| Japan | 9.178.017 Boehringer Ingelheim Investigational Site | Adumino, Nagano | |
| Japan | 9.178.032 Boehringer Ingelheim Investigational Site | Akashi, Hyogo | |
| Japan | 9.178.074 Boehringer Ingelheim Investigational Site | Akashi, Hyogo | |
| Japan | 9.178.062 Boehringer Ingelheim Investigational Site | Ako, Hyogo | |
| Japan | 9.178.064 Boehringer Ingelheim Investigational Site | Aoba-ku, Yokohama, Kanagawa | |
| Japan | 9.178.097 Boehringer Ingelheim Investigational Site | Aoi-ku, Shizuoka, Shizuoka | |
| Japan | 9.178.056 Boehringer Ingelheim Investigational Site | Asahi, Chiba | |
| Japan | 9.178.067 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | |
| Japan | 9.178.117 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | |
| Japan | 9.178.166 Boehringer Ingelheim Investigational Site | Atsugi, Kanagawa | |
| Japan | 9.178.089 Boehringer Ingelheim Investigational Site | Bunkyo-ku, Tokyo | |
| Japan | 9.178.054 Boehringer Ingelheim Investigational Site | Chitose, Hokkaido | |
| Japan | 9.178.133 Boehringer Ingelheim Investigational Site | Chuo-ku, Chiba, Chiba | |
| Japan | 9.178.030 Boehringer Ingelheim Investigational Site | Chuo-ku, Kobe, Hyogo | |
| Japan | 9.178.077 Boehringer Ingelheim Investigational Site | Chuo-ku, Sapporo, Hokkaido | |
| Japan | 9.178.002 Boehringer Ingelheim Investigational Site | Chuo-Ku, Sappro, Hokkaido | |
| Japan | 9.178.119 Boehringer Ingelheim Investigational Site | Chuo-ku, Sappro, Hokkaido | |
| Japan | 9.178.161 Boehringer Ingelheim Investigational Site | Daito, Osaka | |
| Japan | 9.178.112 Boehringer Ingelheim Investigational Site | Fuchu, Tokyo | |
| Japan | 9.178.098 Boehringer Ingelheim Investigational Site | Fujieda, Shizuoka | |
| Japan | 9.178.046 Boehringer Ingelheim Investigational Site | Fukaya, Saitama | |
| Japan | 9.178.145 Boehringer Ingelheim Investigational Site | Fukui, Fukui | |
| Japan | 9.178.099 Boehringer Ingelheim Investigational Site | Fukuroi, Shizuoka | |
| Japan | 9.178.165 Boehringer Ingelheim Investigational Site | Funabashi, Chiba | |
| Japan | 9.178.072 Boehringer Ingelheim Investigational Site | Fushimi-ku, Kyoto, Kyoto | |
| Japan | 9.178.081 Boehringer Ingelheim Investigational Site | Gifu, Gifu | |
| Japan | 9.178.024 Boehringer Ingelheim Investigational Site | Habikino, Osaka | |
| Japan | 9.178.136 Boehringer Ingelheim Investigational Site | Hachioji, Tokyo | |
| Japan | 9.178.082 Boehringer Ingelheim Investigational Site | Hakodate, Hokkaido | |
| Japan | 9.178.118 Boehringer Ingelheim Investigational Site | Hakodate, Hokkaido | |
| Japan | 9.178.052 Boehringer Ingelheim Investigational Site | Hamada, Shimane | |
| Japan | 9.178.138 Boehringer Ingelheim Investigational Site | Hashima-gun, Gifu | |
| Japan | 9.178.169 Boehringer Ingelheim Investigational Site | Hidaka, Saitama | |
| Japan | 9.178.001 Boehringer Ingelheim Investigational Site | Higashi-ku, Sappro, Hokkaido | |
| Japan | 9.178.026 Boehringer Ingelheim Investigational Site | Higashi-osaka, Osaka | |
| Japan | 9.178.163 Boehringer Ingelheim Investigational Site | Higashidakawa-gun, Yamagata | |
| Japan | 9.178.120 Boehringer Ingelheim Investigational Site | Higashimatsushima, Miyagi | |
| Japan | 9.178.028 Boehringer Ingelheim Investigational Site | Higashinari-ku, Osaka, Osaka | |
| Japan | 9.178.140 Boehringer Ingelheim Investigational Site | Higashiosaka, Osaka | |
| Japan | 9.178.122 Boehringer Ingelheim Investigational Site | Higashisonogi-gun, Nagasaki | |
| Japan | 9.178.101 Boehringer Ingelheim Investigational Site | Higashiyodogawa-ku, Osaka, Osaka | |
| Japan | 9.178.093 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | |
| Japan | 9.178.153 Boehringer Ingelheim Investigational Site | Hitachi, Ibaraki | |
| Japan | 9.178.005 Boehringer Ingelheim Investigational Site | Hitachinaka, Ibaraki | |
| Japan | 9.178.079 Boehringer Ingelheim Investigational Site | Ibusuki, Kagoshima | |
| Japan | 9.178.143 Boehringer Ingelheim Investigational Site | Ichikawa, Chiba | |
| Japan | 9.178.019 Boehringer Ingelheim Investigational Site | Iida, Nagano | |
| Japan | 9.178.129 Boehringer Ingelheim Investigational Site | Inashiki-gun, Ibaraki | |
| Japan | 9.178.011 Boehringer Ingelheim Investigational Site | Isesaki, Gunma | |
| Japan | 9.178.045 Boehringer Ingelheim Investigational Site | Isesaki, Gunma | |
| Japan | 9.178.031 Boehringer Ingelheim Investigational Site | Itami, Hyogo | |
| Japan | 9.178.135 Boehringer Ingelheim Investigational Site | Iwanuma, Miyagi | |
| Japan | 9.178.104 Boehringer Ingelheim Investigational Site | Iwata, Shizuoka | |
| Japan | 9.178.095 Boehringer Ingelheim Investigational Site | Izuka, Fukuoka | |
| Japan | 9.178.080 Boehringer Ingelheim Investigational Site | Izumisano, Osaka | |
| Japan | 9.178.139 Boehringer Ingelheim Investigational Site | Izumo, Shimane | |
| Japan | 9.178.113 Boehringer Ingelheim Investigational Site | Izunokuni, Shizuoka | |
| Japan | 9.178.115 Boehringer Ingelheim Investigational Site | Kahoku-gun, Ishikawa | |
| Japan | 9.178.147 Boehringer Ingelheim Investigational Site | Kameda-gun, Hokkaido | |
| Japan | 9.178.092 Boehringer Ingelheim Investigational Site | Kamigyo-ku, Kyoto, Kyoto | |
| Japan | 9.178.008 Boehringer Ingelheim Investigational Site | Kasama, Ibaraki | |
| Japan | 9.178.035 Boehringer Ingelheim Investigational Site | Kasuga, Fukuoka | |
| Japan | 9.178.037 Boehringer Ingelheim Investigational Site | Kasuga, Fukuoka | |
| Japan | 9.178.051 Boehringer Ingelheim Investigational Site | Kawachinagano, Osaka | |
| Japan | 9.178.086 Boehringer Ingelheim Investigational Site | Kisarazu, Chiba | |
| Japan | 9.178.162 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | |
| Japan | 9.178.102 Boehringer Ingelheim Investigational Site | Kita-ku, Nagoya, Aichi | |
| Japan | 9.178.023 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka, Osaka | |
| Japan | 9.178.127 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka, Osaka | |
| Japan | 9.178.004 Boehringer Ingelheim Investigational Site | Kita-ku, Sappro, Hokkaido | |
| Japan | 9.178.154 Boehringer Ingelheim Investigational Site | Kitami, Hokkaido | |
| Japan | 9.178.155 Boehringer Ingelheim Investigational Site | Kitami, Hokkaido | |
| Japan | 9.178.069 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | |
| Japan | 9.178.070 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | |
| Japan | 9.178.121 Boehringer Ingelheim Investigational Site | Kochi, Kochi | |
| Japan | 9.178.141 Boehringer Ingelheim Investigational Site | Kochi, Kochi | |
| Japan | 9.178.061 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | |
| Japan | 9.178.085 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | |
| Japan | 9.178.075 Boehringer Ingelheim Investigational Site | Koshi, Kumamoto | |
| Japan | 9.178.107 Boehringer Ingelheim Investigational Site | Kurashiki, Okayama | |
| Japan | 9.178.063 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | |
| Japan | 9.178.083 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | |
| Japan | 9.178.126 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | |
| Japan | 9.178.150 Boehringer Ingelheim Investigational Site | Marugame, Kagawa | |
| Japan | 9.178.164 Boehringer Ingelheim Investigational Site | Matsudo, Chiba | |
| Japan | 9.178.015 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano | |
| Japan | 9.178.130 Boehringer Ingelheim Investigational Site | Meguro-ku, Tokyo | |
| Japan | 9.178.057 Boehringer Ingelheim Investigational Site | Meito-ku, Nagoya, Aichi | |
| Japan | 9.178.013 Boehringer Ingelheim Investigational Site | Midori-ku, Yokohama, Kanagawa | |
| Japan | 9.178.043 Boehringer Ingelheim Investigational Site | Minami-ku, Hiroshima, Hiroshima | |
| Japan | 9.178.068 Boehringer Ingelheim Investigational Site | Miyagino-ku, Sendai, Miyagi | |
| Japan | 9.178.116 Boehringer Ingelheim Investigational Site | Miyazaki, Miyazaki | |
| Japan | 9.178.142 Boehringer Ingelheim Investigational Site | Moriguchi, Osaka | |
| Japan | 9.178.078 Boehringer Ingelheim Investigational Site | Morioka, Iwate | |
| Japan | 9.178.084 Boehringer Ingelheim Investigational Site | Morioka, Iwate | |
| Japan | 9.178.009 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki | |
| Japan | 9.178.149 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki | |
| Japan | 9.178.071 Boehringer Ingelheim Investigational Site | Musashimurayama, Tokyo | |
| Japan | 9.178.012 Boehringer Ingelheim Investigational Site | Musashino, Tokyo | |
| Japan | 9.178.100 Boehringer Ingelheim Investigational Site | Naka-ku, Hamamatsu, Shizuoka | |
| Japan | 9.178.110 Boehringer Ingelheim Investigational Site | Naka-ku, Hamamatsu, Shizuoka | |
| Japan | 9.178.020 Boehringer Ingelheim Investigational Site | Naka-ku, Nagoya, Aichi | |
| Japan | 9.178.053 Boehringer Ingelheim Investigational Site | Nakagawa-ku, Nagoya, Aichi | |
| Japan | 9.178.132 Boehringer Ingelheim Investigational Site | Nakagawa-ku, Nagoya, Nagoya | |
| Japan | 9.178.124 Boehringer Ingelheim Investigational Site | Namegata, Ibaraki | |
| Japan | 9.178.158 Boehringer Ingelheim Investigational Site | Nanao, Ishikawa | |
| Japan | 9.178.029 Boehringer Ingelheim Investigational Site | Nishi-yodogawa-ku, Osaka, Osaka | |
| Japan | 9.178.096 Boehringer Ingelheim Investigational Site | Nishisonogi-gun, Nagasaki | |
| Japan | 9.178.087 Boehringer Ingelheim Investigational Site | Noda, Chiba | |
| Japan | 9.178.058 Boehringer Ingelheim Investigational Site | Obu, Aichi | |
| Japan | 9.178.034 Boehringer Ingelheim Investigational Site | Ohnojo, Fukuoka | |
| Japan | 9.178.157 Boehringer Ingelheim Investigational Site | Okayama, Okayama | |
| Japan | 9.178.167 Boehringer Ingelheim Investigational Site | Okinawa, Okinawa | |
| Japan | 9.178.137 Boehringer Ingelheim Investigational Site | Sagamihara, Kanagawa | |
| Japan | 9.178.027 Boehringer Ingelheim Investigational Site | Sakai, Osaka | |
| Japan | 9.178.073 Boehringer Ingelheim Investigational Site | Sakai, Osaka | |
| Japan | 9.178.018 Boehringer Ingelheim Investigational Site | Saku, Nagano | |
| Japan | 9.178.160 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | |
| Japan | 9.178.041 Boehringer Ingelheim Investigational Site | Setagaya-ku, Tokyo | |
| Japan | 9.178.088 Boehringer Ingelheim Investigational Site | Shibuya-ku, Tokyo | |
| Japan | 9.178.022 Boehringer Ingelheim Investigational Site | Shimogyo-ku, Kyoto, Kyoto | |
| Japan | 9.178.076 Boehringer Ingelheim Investigational Site | Shimotsuke, Tochigi | |
| Japan | 9.178.055 Boehringer Ingelheim Investigational Site | Shiroishi, Miyagi | |
| Japan | 9.178.111 Boehringer Ingelheim Investigational Site | Simizu-ku, Shizuoka, Shizuoka | |
| Japan | 9.178.151 Boehringer Ingelheim Investigational Site | Suminoe-ku, Osaka, Osaka | |
| Japan | 9.178.156 Boehringer Ingelheim Investigational Site | Susono, Shizuoka | |
| Japan | 9.178.014 Boehringer Ingelheim Investigational Site | Suwa, Nagano | |
| Japan | 9.178.039 Boehringer Ingelheim Investigational Site | Takasaki, Gunma | |
| Japan | 9.178.146 Boehringer Ingelheim Investigational Site | Takatsuki, Osaka | |
| Japan | 9.178.144 Boehringer Ingelheim Investigational Site | Takayama, Gifu | |
| Japan | 9.178.003 Boehringer Ingelheim Investigational Site | Takikawa, Hokkaido | |
| Japan | 9.178.040 Boehringer Ingelheim Investigational Site | Tatebayashi, Gunma | |
| Japan | 9.178.066 Boehringer Ingelheim Investigational Site | Teine-ku, Sapporo, Hokkaido | |
| Japan | 9.178.134 Boehringer Ingelheim Investigational Site | Tenri, Nara | |
| Japan | 9.178.159 Boehringer Ingelheim Investigational Site | Tonami, Toyama | |
| Japan | 9.178.007 Boehringer Ingelheim Investigational Site | Toride, Ibaraki | |
| Japan | 9.178.047 Boehringer Ingelheim Investigational Site | Toyama, Toyama | |
| Japan | 9.178.090 Boehringer Ingelheim Investigational Site | Toyohashi, Aichi | |
| Japan | 9.178.131 Boehringer Ingelheim Investigational Site | Toyota, Aichi | |
| Japan | 9.178.006 Boehringer Ingelheim Investigational Site | Tsuchiura, Ibaraki | |
| Japan | 9.178.016 Boehringer Ingelheim Investigational Site | Ueda, Nagano | |
| Japan | 9.178.091 Boehringer Ingelheim Investigational Site | Uji, Kyoto | |
| Japan | 9.178.050 Boehringer Ingelheim Investigational Site | Ukyo-ku, Kyoto, Kyoto | |
| Japan | 9.178.106 Boehringer Ingelheim Investigational Site | Urayasu, Chiba | |
| Japan | 9.178.148 Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | |
| Japan | 9.178.114 Boehringer Ingelheim Investigational Site | Wko, Saitama | |
| Japan | 9.178.152 Boehringer Ingelheim Investigational Site | Yaizu, Shizuoka | |
| Japan | 9.178.125 Boehringer Ingelheim Investigational Site | Yamashina, Kyoto, Kyoto | |
| Japan | 9.178.108 Boehringer Ingelheim Investigational Site | Yanai, Yamaguchi | |
| Japan | 9.178.103 Boehringer Ingelheim Investigational Site | Yao, Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Brain (Cerebral) Haemorrhage | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Subarachnoid Haemorrhage | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Transient Ischemic Attack (TIA) | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Acute Coronary Syndrome (ACS) | ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Other Vascular Events | This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
| Secondary | Number of Patients With Ischemic Vascular Event Composite Endpoint | This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. | Up to 124 weeks | No |
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