JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

NCT00311402 | Completed Phase 3 Results

• 1 other identifier: 9.178
• Study Type: interventional
• Target: 1,295
• Locations: 1 country
• Sites: 151

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

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Number of Patients With Brain (Cerebral) Haemorrhage

  Up to 124 weeks

• Number of Patients With Subarachnoid Haemorrhage

  Up to 124 weeks

• Number of Patients With Transient Ischemic Attack (TIA)

  Up to 124 weeks

• Number of Patients With Acute Coronary Syndrome (ACS)

  Up to 124 weeks

• Number of Patients With Other Vascular Events

  Up to 124 weeks

Study Arms (2)

Aggrenox Capsule

OTHER

Drug: Aggrenox capsule

Acetylsalicylic Acid (ASA) 81 mg Tablet

OTHER

Other: Acetylsalicylic Acid (ASA)

Interventions

Aggrenox capsule DRUG

extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily

Aggrenox Capsule

Acetylsalicylic Acid (ASA) OTHER

Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily

Acetylsalicylic Acid (ASA) 81 mg Tablet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• Patients who are 50 years or older
• Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
• Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (151)

9.178.060 Boehringer Ingelheim Investigational Site

Adachi-ku, Tokyo, Japan

Location

9.178.017 Boehringer Ingelheim Investigational Site

Adumino, Nagano, Japan

Location

9.178.032 Boehringer Ingelheim Investigational Site

Akashi, Hyogo, Japan

Location

9.178.074 Boehringer Ingelheim Investigational Site

Akashi, Hyogo, Japan

Location

9.178.062 Boehringer Ingelheim Investigational Site

Ako, Hyogo, Japan

Location

9.178.064 Boehringer Ingelheim Investigational Site

Aoba-ku, Yokohama, Kanagawa, Japan

Location

9.178.097 Boehringer Ingelheim Investigational Site

Aoi-ku, Shizuoka, Shizuoka, Japan

Location

9.178.056 Boehringer Ingelheim Investigational Site

Asahi, Chiba, Japan

Location

9.178.067 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, Japan

Location

9.178.117 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, Japan

Location

9.178.166 Boehringer Ingelheim Investigational Site

Atsugi, Kanagawa, Japan

Location

9.178.089 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

9.178.054 Boehringer Ingelheim Investigational Site

Chitose, Hokkaido, Japan

Location

9.178.133 Boehringer Ingelheim Investigational Site

Chuo-ku, Chiba, Chiba, Japan

Location

9.178.030 Boehringer Ingelheim Investigational Site

Chuo-ku, Kobe, Hyogo, Japan

Location

9.178.077 Boehringer Ingelheim Investigational Site

Chuo-ku, Sapporo, Hokkaido, Japan

Location

9.178.002 Boehringer Ingelheim Investigational Site

Chuo-Ku, Sappro, Hokkaido, Japan

Location

9.178.119 Boehringer Ingelheim Investigational Site

Chuo-ku, Sappro, Hokkaido, Japan

Location

9.178.161 Boehringer Ingelheim Investigational Site

Daito, Osaka, Japan

Location

9.178.112 Boehringer Ingelheim Investigational Site

Fuchu, Tokyo, Japan

Location

9.178.098 Boehringer Ingelheim Investigational Site

Fujieda, Shizuoka, Japan

Location

9.178.046 Boehringer Ingelheim Investigational Site

Fukaya, Saitama, Japan

Location

9.178.145 Boehringer Ingelheim Investigational Site

Fukui, Fukui, Japan

Location

9.178.099 Boehringer Ingelheim Investigational Site

Fukuroi, Shizuoka, Japan

Location

9.178.165 Boehringer Ingelheim Investigational Site

Funabashi, Chiba, Japan

Location

9.178.072 Boehringer Ingelheim Investigational Site

Fushimi-ku, Kyoto, Kyoto, Japan

Location

9.178.081 Boehringer Ingelheim Investigational Site

Gifu, Gifu, Japan

Location

9.178.024 Boehringer Ingelheim Investigational Site

Habikino, Osaka, Japan

Location

9.178.136 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, Japan

Location

9.178.082 Boehringer Ingelheim Investigational Site

Hakodate, Hokkaido, Japan

Location

9.178.118 Boehringer Ingelheim Investigational Site

Hakodate, Hokkaido, Japan

Location

9.178.052 Boehringer Ingelheim Investigational Site

Hamada, Shimane, Japan

Location

9.178.138 Boehringer Ingelheim Investigational Site

Hashima-gun, Gifu, Japan

Location

9.178.169 Boehringer Ingelheim Investigational Site

Hidaka, Saitama, Japan

Location

9.178.001 Boehringer Ingelheim Investigational Site

Higashi-ku, Sappro, Hokkaido, Japan

Location

9.178.026 Boehringer Ingelheim Investigational Site

Higashi-osaka, Osaka, Japan

Location

9.178.163 Boehringer Ingelheim Investigational Site

Higashidakawa-gun, Yamagata, Japan

Location

9.178.120 Boehringer Ingelheim Investigational Site

Higashimatsushima, Miyagi, Japan

Location

9.178.028 Boehringer Ingelheim Investigational Site

Higashinari-ku, Osaka, Osaka, Japan

Location

9.178.140 Boehringer Ingelheim Investigational Site

Higashiosaka, Osaka, Japan

Location

9.178.122 Boehringer Ingelheim Investigational Site

Higashisonogi-gun, Nagasaki, Japan

Location

9.178.101 Boehringer Ingelheim Investigational Site

Higashiyodogawa-ku, Osaka, Osaka, Japan

Location

9.178.093 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

9.178.153 Boehringer Ingelheim Investigational Site

Hitachi, Ibaraki, Japan

Location

9.178.005 Boehringer Ingelheim Investigational Site

Hitachinaka, Ibaraki, Japan

Location

9.178.079 Boehringer Ingelheim Investigational Site

Ibusuki, Kagoshima, Japan

Location

9.178.143 Boehringer Ingelheim Investigational Site

Ichikawa, Chiba, Japan

Location

9.178.019 Boehringer Ingelheim Investigational Site

Iida, Nagano, Japan

Location

9.178.129 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, Japan

Location

9.178.011 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, Japan

Location

9.178.045 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, Japan

Location

9.178.031 Boehringer Ingelheim Investigational Site

Itami, Hyogo, Japan

Location

9.178.135 Boehringer Ingelheim Investigational Site

Iwanuma, Miyagi, Japan

Location

9.178.104 Boehringer Ingelheim Investigational Site

Iwata, Shizuoka, Japan

Location

9.178.095 Boehringer Ingelheim Investigational Site

Izuka, Fukuoka, Japan

Location

9.178.080 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, Japan

Location

9.178.139 Boehringer Ingelheim Investigational Site

Izumo, Shimane, Japan

Location

9.178.113 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, Japan

Location

9.178.115 Boehringer Ingelheim Investigational Site

Kahoku-gun, Ishikawa, Japan

Location

9.178.147 Boehringer Ingelheim Investigational Site

Kameda-gun, Hokkaido, Japan

Location

9.178.092 Boehringer Ingelheim Investigational Site

Kamigyo-ku, Kyoto, Kyoto, Japan

Location

9.178.008 Boehringer Ingelheim Investigational Site

Kasama, Ibaraki, Japan

Location

9.178.035 Boehringer Ingelheim Investigational Site

Kasuga, Fukuoka, Japan

Location

9.178.037 Boehringer Ingelheim Investigational Site

Kasuga, Fukuoka, Japan

Location

9.178.051 Boehringer Ingelheim Investigational Site

Kawachinagano, Osaka, Japan

Location

9.178.086 Boehringer Ingelheim Investigational Site

Kisarazu, Chiba, Japan

Location

9.178.162 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, Japan

Location

9.178.102 Boehringer Ingelheim Investigational Site

Kita-ku, Nagoya, Aichi, Japan

Location

9.178.023 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, Osaka, Japan

Location

9.178.127 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, Osaka, Japan

Location

9.178.004 Boehringer Ingelheim Investigational Site

Kita-ku, Sappro, Hokkaido, Japan

Location

9.178.154 Boehringer Ingelheim Investigational Site

Kitami, Hokkaido, Japan

Location

9.178.155 Boehringer Ingelheim Investigational Site

Kitami, Hokkaido, Japan

Location

9.178.069 Boehringer Ingelheim Investigational Site

Kiyose, Tokyo, Japan

Location

9.178.070 Boehringer Ingelheim Investigational Site

Kiyose, Tokyo, Japan

Location

9.178.121 Boehringer Ingelheim Investigational Site

Kochi, Kochi, Japan

Location

9.178.141 Boehringer Ingelheim Investigational Site

Kochi, Kochi, Japan

Location

9.178.061 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

9.178.085 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

9.178.075 Boehringer Ingelheim Investigational Site

Koshi, Kumamoto, Japan

Location

9.178.107 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

Location

9.178.063 Boehringer Ingelheim Investigational Site

Kushiro, Japan

Location

9.178.083 Boehringer Ingelheim Investigational Site

Kushiro, Japan

Location

9.178.126 Boehringer Ingelheim Investigational Site

Kushiro, Japan

Location

9.178.150 Boehringer Ingelheim Investigational Site

Marugame, Kagawa, Japan

Location

9.178.164 Boehringer Ingelheim Investigational Site

Matsudo, Chiba, Japan

Location

9.178.015 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

Location

9.178.130 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

9.178.057 Boehringer Ingelheim Investigational Site

Meito-ku, Nagoya, Aichi, Japan

Location

9.178.013 Boehringer Ingelheim Investigational Site

Midori-ku, Yokohama, Kanagawa, Japan

Location

9.178.043 Boehringer Ingelheim Investigational Site

Minami-ku, Hiroshima, Hiroshima, Japan

Location

9.178.068 Boehringer Ingelheim Investigational Site

Miyagino-ku, Sendai, Miyagi, Japan

Location

9.178.116 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, Japan

Location

9.178.142 Boehringer Ingelheim Investigational Site

Moriguchi, Osaka, Japan

Location

9.178.078 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

9.178.084 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

9.178.009 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, Japan

Location

9.178.149 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, Japan

Location

9.178.071 Boehringer Ingelheim Investigational Site

Musashimurayama, Tokyo, Japan

Location

9.178.012 Boehringer Ingelheim Investigational Site

Musashino, Tokyo, Japan

Location

9.178.100 Boehringer Ingelheim Investigational Site

Naka-ku, Hamamatsu, Shizuoka, Japan

Location

9.178.110 Boehringer Ingelheim Investigational Site

Naka-ku, Hamamatsu, Shizuoka, Japan

Location

9.178.020 Boehringer Ingelheim Investigational Site

Naka-ku, Nagoya, Aichi, Japan

Location

9.178.053 Boehringer Ingelheim Investigational Site

Nakagawa-ku, Nagoya, Aichi, Japan

Location

9.178.132 Boehringer Ingelheim Investigational Site

Nakagawa-ku, Nagoya, Nagoya, Japan

Location

9.178.124 Boehringer Ingelheim Investigational Site

Namegata, Ibaraki, Japan

Location

9.178.158 Boehringer Ingelheim Investigational Site

Nanao, Ishikawa, Japan

Location

9.178.029 Boehringer Ingelheim Investigational Site

Nishi-yodogawa-ku, Osaka, Osaka, Japan

Location

9.178.096 Boehringer Ingelheim Investigational Site

Nishisonogi-gun, Nagasaki, Japan

Location

9.178.087 Boehringer Ingelheim Investigational Site

Noda, Chiba, Japan

Location

9.178.058 Boehringer Ingelheim Investigational Site

Obu, Aichi, Japan

Location

9.178.034 Boehringer Ingelheim Investigational Site

Ohnojo, Fukuoka, Japan

Location

9.178.157 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

9.178.167 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

9.178.137 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

9.178.027 Boehringer Ingelheim Investigational Site

Sakai, Osaka, Japan

Location

9.178.073 Boehringer Ingelheim Investigational Site

Sakai, Osaka, Japan

Location

9.178.018 Boehringer Ingelheim Investigational Site

Saku, Nagano, Japan

Location

9.178.160 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

9.178.041 Boehringer Ingelheim Investigational Site

Setagaya-ku, Tokyo, Japan

Location

9.178.088 Boehringer Ingelheim Investigational Site

Shibuya-ku, Tokyo, Japan

Location

9.178.022 Boehringer Ingelheim Investigational Site

Shimogyo-ku, Kyoto, Kyoto, Japan

Location

9.178.076 Boehringer Ingelheim Investigational Site

Shimotsuke, Tochigi, Japan

Location

9.178.055 Boehringer Ingelheim Investigational Site

Shiroishi, Miyagi, Japan

Location

9.178.111 Boehringer Ingelheim Investigational Site

Simizu-ku, Shizuoka, Shizuoka, Japan

Location

9.178.151 Boehringer Ingelheim Investigational Site

Suminoe-ku, Osaka, Osaka, Japan

Location

9.178.156 Boehringer Ingelheim Investigational Site

Susono, Shizuoka, Japan

Location

9.178.014 Boehringer Ingelheim Investigational Site

Suwa, Nagano, Japan

Location

9.178.039 Boehringer Ingelheim Investigational Site

Takasaki, Gunma, Japan

Location

9.178.146 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, Japan

Location

9.178.144 Boehringer Ingelheim Investigational Site

Takayama, Gifu, Japan

Location

9.178.003 Boehringer Ingelheim Investigational Site

Takikawa, Hokkaido, Japan

Location

9.178.040 Boehringer Ingelheim Investigational Site

Tatebayashi, Gunma, Japan

Location

9.178.066 Boehringer Ingelheim Investigational Site

Teine-ku, Sapporo, Hokkaido, Japan

Location

9.178.134 Boehringer Ingelheim Investigational Site

Tenri, Nara, Japan

Location

9.178.159 Boehringer Ingelheim Investigational Site

Tonami, Toyama, Japan

Location

9.178.007 Boehringer Ingelheim Investigational Site

Toride, Ibaraki, Japan

Location

9.178.047 Boehringer Ingelheim Investigational Site

Toyama, Toyama, Japan

Location

9.178.090 Boehringer Ingelheim Investigational Site

Toyohashi, Aichi, Japan

Location

9.178.131 Boehringer Ingelheim Investigational Site

Toyota, Aichi, Japan

Location

9.178.006 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, Japan

Location

9.178.016 Boehringer Ingelheim Investigational Site

Ueda, Nagano, Japan

Location

9.178.091 Boehringer Ingelheim Investigational Site

Uji, Kyoto, Japan

Location

9.178.050 Boehringer Ingelheim Investigational Site

Ukyo-ku, Kyoto, Kyoto, Japan

Location

9.178.106 Boehringer Ingelheim Investigational Site

Urayasu, Chiba, Japan

Location

9.178.148 Boehringer Ingelheim Investigational Site

Wakayama, Wakayama, Japan

Location

9.178.114 Boehringer Ingelheim Investigational Site

Wko, Saitama, Japan

Location

9.178.152 Boehringer Ingelheim Investigational Site

Yaizu, Shizuoka, Japan

Location

9.178.125 Boehringer Ingelheim Investigational Site

Yamashina, Kyoto, Kyoto, Japan

Location

9.178.108 Boehringer Ingelheim Investigational Site

Yanai, Yamaguchi, Japan

Location

9.178.103 Boehringer Ingelheim Investigational Site

Yao, Osaka, Japan

Location

Related Publications (1)

• 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.

  PMID: 21502757 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Aspirin, Dipyridamole Drug Combination; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: April 6, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2009
• Last Updated: February 14, 2014
• Results First Posted: March 11, 2010

Record last verified: 2014-01

Locations

JP (151)