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JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
This study has been completed.
First Received: March 28, 2006   Last Updated: May 25, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00311402
  Purpose

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


Condition Intervention Phase
Cerebrovascular Accident
Drug: Aggrenox capsule
Drug: ASA 81 mg tablet
Phase III

Study Type: Interventional
Study Design: Prevention, Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Recurrence of brain infarction (fatal or non-fatal) [ Time Frame: 52 weeks to 124 weeks ]

Secondary Outcome Measures:
  • Brain hemorrhage Subarachnoid hemorrhage Transient ischemic attack (TIA) Acute coronary syndromes (myocardial infarction, angina unstable, cardiac death) Other vascular events [ Time Frame: 52 weeks to 124 weeks ]

Enrollment: 1295
Study Start Date: April 2006
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CT or 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 (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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311402

  Hide Study Locations
Locations
Japan
9.178.054 Chitose Houyukai Hospital
Chitose, Hokkaido, Japan
9.178.055 Katta Hospital
Shiroishi, Miyagi, Japan
9.178.056 Asahi General Hospital
Asahi, Chiba, Japan
9.178.057 National Hospital Organization Higashinagoya Hospital
Meito-ku, Nagoya, Aichi, Japan
9.178.058 National Hospital for Geriatric Medicine, NCGG
Obu, Aichi, Japan
9.178.060 Asahi Hospital
Adachi-ku, Tokyo, Japan
9.178.061 Southern TOHOKU Research Institute for Neuroscience Southern
Koriyama, Fukushima, Japan
9.178.063 Kushiro Rosai Hospital
Kushiro, Hokkaido, Japan
9.178.064 Yokohama Shintoshi Neurosurgical Hospital
Aoba-ku, Yokohama, Kanagawa, Japan
9.178.001 Teishinkai Hospital
Higashi-ku, Sappro, Hokkaido, Japan
9.178.002 Miyanomori Memorial Hospital
Chuo-Ku, Sappro, Hokkaido, Japan
9.178.003 Takikawa Neurosurgical Hospital
Takikawa, Hokkaido, Japan
9.178.004 Sappro Kita Neurosurgery
Kita-ku, Sappro, Hokkaido, Japan
9.178.005 Hitachi, Ltd., Mito General Hospital
Hitachinaka, Ibaraki, Japan
9.178.006 Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, Japan
9.178.007 Toride Kyodo General Hospital
Toride, Ibaraki, Japan
9.178.008 Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, Japan
9.178.009 Moriya Keiyu Hospital
Moriya, Ibaraki, Japan
9.178.011 Isesaki Municipal Hospital
Isesaki, Gunma, Japan
9.178.012 Kichijoji Minami Hospital
Musashino, Tokyo, Japan
9.178.013 Yokohama Shin-midori Hospital
Midori-ku, Yokohama, Kanagawa, Japan
9.178.014 Suwa Red Cross Hospital
Suwa, Nagano, Japan
9.178.015 Aizawa Hospital
Matsumoto, Nagano, Japan
9.178.016 Kakeyu Hospital
Ueda, Nagano, Japan
9.178.018 Saku Central Hospital
Saku, Nagano, Japan
9.178.019 Seguchi Neurosurgery Hospital
Iida, Nagano, Japan
9.178.020 National Hospital Organization Nagoya Medical Center
Naka-ku, Nagoya, Aichi, Japan
9.178.022 Tatsuoka Neurology Clinic
Shimogyo-ku, Kyoto, Kyoto, Japan
9.178.023 Kitano Hospital, The Tazuke Kofukai Medical Research Institu
Kita-ku, Osaka, Osaka, Japan
9.178.024 Shiroyama Hospital
Habikino, Osaka, Japan
9.178.026 Ishikiriseiki Hospital
Higashi-osaka, Osaka, Japan
9.178.027 Sakai Municipal Hospital
Sakai, Osaka, Japan
9.178.028 Yagi Neurosurgical Hospital
Higashinari-ku, Osaka, Osaka, Japan
9.178.029 Chibune Clinics
Nishi-yodogawa-ku, Osaka, Osaka, Japan
9.178.030 Shinko Hospital
Chuo-ku, Kobe, Hyogo, Japan
9.178.031 Kinki Central Hospital of the Mutual Aid Association
Itami, Hyogo, Japan
9.178.034 Bunyukai Hara Hospital
Ohnojo, Fukuoka, Japan
9.178.035 Fukuoka Tokushukai Medical Center
Kasuga, Fukuoka, Japan
9.178.037 Jinnouchi Neurosurgical Clinic
Kasuga, Fukuoka, Japan
9.178.039 Kurosawa Hospital
Takasaki, Gunma, Japan
9.178.040 Tatebayashi Kosei Hospital
Tatebayashi, Gunma, Japan
9.178.041 Kanto Central Hospital of the Mutual Aid Association
Setagaya-ku, Tokyo, Japan
9.178.043 Hiroshima Prefectural Hospital
Minami-ku, Hiroshima, Hiroshima, Japan
9.178.045 Mihara Memorial Hospital Institute
Isesaki, Gunma, Japan
9.178.046 Fukaya Red Cross Hospital
Fukaya, Saitama, Japan
9.178.047 Toyama University Hospital
Toyama, Toyama, Japan
9.178.051 National Organization Osaka Minami Medical Center
Kawachinagano, Osaka, Japan
9.178.052 National Hospital Organization Hamada Medical Center
Hamada, Shimane, Japan
9.178.032 Toda Orthopedics & Neuromedicine Clinic
Akashi, Hyogo, Japan
9.178.053 Nagoya Kyouritsu Clinic
Nakagawa-ku, Nagoya, Aichi, Japan
9.178.106 Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
9.178.107 Mizushima Central Hospital
Kurashiki, Okayama, Japan
9.178.108 Shuto General Hospital
Yanai, Yamaguchi, Japan
9.178.110 JA Shizuoka Kohseiren Enshu Hospital
Naka-ku, Hamamatsu, Shizuoka, Japan
9.178.111 Shizuoka Municipal Shimizu Hospital
Simizu-ku, Shizuoka, Shizuoka, Japan
9.178.112 Nishiharacho Neuro-Surgical Clinic
Fuchu, Tokyo, Japan
9.178.113 Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
9.178.114 National Hospital Organization Saitama Hospital
Wko, Saitama, Japan
9.178.116 Junwakai Memorial Hospital
Miyazaki, Miyazaki, Japan
9.178.139 Shimane University Hospital
Izumo, Shimane, Japan
9.178.140 Higashiosaka City General Hospital
Higashiosaka, Osaka, Japan
9.178.141 Izumino Hospital
Kochi, Kochi, Japan
9.178.143 Ichikawa East Hospital
Ichikawa, Chiba, Japan
9.178.144 Takayama Red Cross Hospital
Takayama, Gifu, Japan
9.178.145 Fukui General Hospital
Fukui, Fukui, Japan
9.178.146 Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
9.178.082 Hakodate Shintoshi Hospital
Hakodate, Hokkaido, Japan
9.178.083 Kushiro Neurosurgical Hospital
Kushiro, Hokkaido, Japan
9.178.084 Matsuzono Secondly Hospital
Morioka, Iwate, Japan
9.178.085 Ohta General Hospital Foundation
Koriyama, Fukushima, Japan
9.178.086 Kimitsu Chuo Hospital
Kisarazu, Chiba, Japan
9.178.087 Kobarisogo Clinic
Noda, Chiba, Japan
9.178.088 Tokai University Tokyo Hospital
Shibuya-ku, Tokyo, Japan
9.178.090 National Hospital Organization Toyohashi Medical Center
Toyohashi, Aichi, Japan
9.178.091 Uji Hospital
Uji, Kyoto, Japan
9.178.164 Chibanishi General Hospital
Matsudo, Chiba, Japan
9.178.093 Hyogo Brain and Heart Center
Himeji, Hyogo, Japan
9.178.095 Iizuka Hospital
Izuka, Fukuoka, Japan
9.178.096 Nagasaki Kita Hospital
Nishisonogi-gun, Nagasaki, Japan
9.178.097 Shizuoka General Hospital
Aoi-ku, Shizuoka, Shizuoka, Japan
9.178.098 Fujieda Municipal General Hospital
Fujieda, Shizuoka, Japan
9.178.099 Fukuroi Municipal Hospital
Fukuroi, Shizuoka, Japan
9.178.100 Hamamatsu Medical Center
Naka-ku, Hamamatsu, Shizuoka, Japan
9.178.101 Iseikai Hospital
Higashiyodogawa-ku, Osaka, Osaka, Japan
9.178.102 Kamiiida Daiichi Hospital
Kita-ku, Nagoya, Aichi, Japan
9.178.103 Ishinkai Medical Corporation Ishinkai General Clinics
Yao, Osaka, Japan
9.178.104 Iwata City Hospital
Iwata, Shizuoka, Japan
9.178.117 Asahikawa Red Cross Hospital
Asahikawa, Hokkaido, Japan
9.178.118 Hakodate Neurosurgical Hospital
Hakodate, Hokkaido, Japan
9.178.119 Nakamura Memorial Hospital
Chuo-ku, Sappro, Hokkaido, Japan
9.178.120 Senseki Hospital
Higashimatsushima, Miyagi, Japan
9.178.121 Chikamori Hospital
Kochi, Kochi, Japan
9.178.122 Nagasaki Medical Center Of Neurology
Higashisonogi-gun, Nagasaki, Japan
9.178.124 Namegata District General Hospital
Namegata, Ibaraki, Japan
9.178.125 Rakuwakai Otowa Hospital
Yamashina, Kyoto, Kyoto, Japan
9.178.126 Hoshigaura Hospital
Kushiro, Hokkaido, Japan
9.178.127 Saiseikai Nakatsu Hospital, OSAKA
Kita-ku, Osaka, Osaka, Japan
9.178.129 Ibaraki Prefectural University of Health Sciences Hospital
Inashiki-gun, Ibaraki, Japan
9.178.130 Tokyo Kyosai Hospital
Meguro-ku, Tokyo, Japan
9.178.131 Toyota Motor Corporation Toyota Memorial Hospital
Toyota, Aichi, Japan
9.178.132 Japan Seafarers Relief Association Nagoya Ekisaikai Hospital
Nakagawa-ku, Nagoya, Nagoya, Japan
9.178.080 Rinku General Medical Center Izumisano Municipal Hospital
Izumisano, Osaka, Japan
9.178.133 National Hospital Organization Chiba Medical Center
Chuo-ku, Chiba, Chiba, Japan
9.178.066 Teine Keizinkai Hospital
Teine-ku, Sapporo, Hokkaido, Japan
9.178.067 Asahikawa Rehabilitation Hospital
Asahikawa, Hokkaido, Japan
9.178.068 Sendai Medical Center
Miyagino-ku, Sendai, Miyagi, Japan
9.178.069 National Hospital Organization Tokyo Hospital
Kiyose, Tokyo, Japan
9.178.070 National Hospital Organization Tokyo Hospital
Kiyose, Tokyo, Japan
9.178.071 National Hospital Organization Murayama Medical Center
Musashimurayama, Tokyo, Japan
9.178.072 Ijinkai Takeda General Hospital
Fushimi-ku, Kyoto, Kyoto, Japan
9.178.073 Sakai Hospital Kinki University school of medicine
Sakai, Osaka, Japan
9.178.075 Kumamoto Saishunso National Hospital
Koshi, Kumamoto, Japan
9.178.076 Jichi Medical School Hospital
Shimotsuke, Tochigi, Japan
9.178.077 Hokkaido Neurosurgical Memorial Hospital
Chuo-ku, Sapporo, Hokkaido, Japan
9.178.078 School of Medicine Iwate Medical University
Morioka, Iwate, Japan
9.178.079 National Hospital Organization Ibusuki Hospital
Ibusuki, Kagoshima, Japan
9.178.081 Murakami Memorial Hospital
Gifu, Gifu, Japan
9.178.134 Tenri Hospital
Tenri, Nara, Japan
9.178.135 General Minami Tohoku Hospital
Iwanuma, Miyagi, Japan
9.178.136 Kitahara Neurosurgical Institute
Hachioji, Tokyo, Japan
9.178.137 National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
9.178.138 Matsunami General Hospital
Hashima-gun, Gifu, Japan
9.178.147 Hakodate Neurosurgical Nanae Clinic
Kameda-gun, Hokkaido, Japan
9.178.148 Saiseikai Wakayama Hospital
Wakayama, Wakayama, Japan
9.178.149 Aida Kinen Rehabilitation Hospital
Moriya, Ibaraki, Japan
9.178.150 Kagawa Rosai Hospital
Marugame, Kagawa, Japan
9.178.151 Yuaikai Hospital
Suminoe-ku, Osaka, Osaka, Japan
9.178.152 Yaizu City Hospital
Yaizu, Shizuoka, Japan
9.178.153 Hitachi General Hospital
Hitachi, Ibaraki, Japan
9.178.154 Hokusei Neurosurgical Hospital
Kitami, Hokkaido, Japan
9.178.155 Doto Neurosurgical Hospital
Kitami, Hokkaido, Japan
9.178.156 Oka Neurocare Clinic
Susono, Shizuoka, Japan
9.178.157 Okayama Rosai Hospital
Okayama, Okayama, Japan
9.178.158 Keiju Medical Center Hospital
Nanao, Ishikawa, Japan
9.178.159 Tonami General Hospital
Tonami, Toyama, Japan
9.178.160 Sapporo Higashi Tokusyukai Hospital
Sapporo, Hokkaido, Japan
9.178.161 Nozaki Tokushukai Hospital
Daito, Osaka, Japan
9.178.162 Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
9.178.163 Shonai Amarume Hospital
Higashidakawa-gun, Yamagata, Japan
9.178.165 Chiba Tokushukai Hospital
Funabashi, Chiba, Japan
9.178.166 Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan
9.178.167 Chubu Tokushukai Hospital
Okinawa, Okinawa, Japan
9.178.169 Boehringer Ingelheim Investigational Site
Hidaka, Saitama, Japan
9.178.017 Azumino Red Cross hospital
Adumino, Nagano, Japan
9.178.050 Utano National Hospital Organization
Ukyo-ku, Kyoto, Kyoto, Japan
9.178.062 Ako Central Clinic
Ako, Hyogo, Japan
9.178.074 Ohnishi Nerosurgical Hospital
Akashi, Hyogo, Japan
9.178.089 Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
9.178.115 Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa, Japan
9.178.142 Matsushita Memorial Hospital
Moriguchi, Osaka, Japan
9.178.092 Kyoto Second Red Cross Hospital
Kamigyo-ku, Kyoto, Kyoto, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 9.178
Study First Received: March 28, 2006
Last Updated: May 25, 2009
ClinicalTrials.gov Identifier: NCT00311402     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Brain Infarction
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009