Cerebrovascular AccidentPhase 3NCT00311402

JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

A Phase 3 study testing Aggrenox capsule and Acetylsalicylic Acid (ASA) in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 151 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Cerebrovascular Accident
What is being tested?: Aggrenox capsule and Acetylsalicylic Acid (ASA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,295 participants
Where: 151 sitesJapan
Study dates: Apr 2006to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 13Show fewer

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

151 sites in 1 country.

City, postcode or hospital

151 sites in 1 country

Japan151 sites

9.178.060 Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo
9.178.017 Boehringer Ingelheim Investigational Site
Adumino, Nagano
9.178.032 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
9.178.074 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
9.178.062 Boehringer Ingelheim Investigational Site
Ako, Hyogo
9.178.064 Boehringer Ingelheim Investigational Site
Aoba-ku, Yokohama, Kanagawa
9.178.097 Boehringer Ingelheim Investigational Site
Aoi-ku, Shizuoka, Shizuoka
9.178.056 Boehringer Ingelheim Investigational Site
Asahi, Chiba
9.178.067 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
9.178.117 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
9.178.166 Boehringer Ingelheim Investigational Site
Atsugi, Kanagawa
9.178.089 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
9.178.054 Boehringer Ingelheim Investigational Site
Chitose, Hokkaido
9.178.133 Boehringer Ingelheim Investigational Site
Chuo-ku, Chiba, Chiba
9.178.030 Boehringer Ingelheim Investigational Site
Chuo-ku, Kobe, Hyogo
9.178.077 Boehringer Ingelheim Investigational Site
Chuo-ku, Sapporo, Hokkaido
9.178.119 Boehringer Ingelheim Investigational Site
Chuo-ku, Sappro, Hokkaido
9.178.002 Boehringer Ingelheim Investigational Site
Chuo-Ku, Sappro, Hokkaido
9.178.161 Boehringer Ingelheim Investigational Site
Daito, Osaka
9.178.112 Boehringer Ingelheim Investigational Site
Fuchu, Tokyo
9.178.098 Boehringer Ingelheim Investigational Site
Fujieda, Shizuoka
9.178.046 Boehringer Ingelheim Investigational Site
Fukaya, Saitama
9.178.145 Boehringer Ingelheim Investigational Site
Fukui, Fukui
9.178.099 Boehringer Ingelheim Investigational Site
Fukuroi, Shizuoka
9.178.165 Boehringer Ingelheim Investigational Site
Funabashi, Chiba
9.178.072 Boehringer Ingelheim Investigational Site
Fushimi-ku, Kyoto, Kyoto
9.178.081 Boehringer Ingelheim Investigational Site
Gifu, Gifu
9.178.024 Boehringer Ingelheim Investigational Site
Habikino, Osaka
9.178.136 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo
9.178.082 Boehringer Ingelheim Investigational Site
Hakodate, Hokkaido
9.178.118 Boehringer Ingelheim Investigational Site
Hakodate, Hokkaido
9.178.052 Boehringer Ingelheim Investigational Site
Hamada, Shimane
9.178.138 Boehringer Ingelheim Investigational Site
Hashima-gun, Gifu
9.178.169 Boehringer Ingelheim Investigational Site
Hidaka, Saitama
9.178.001 Boehringer Ingelheim Investigational Site
Higashi-ku, Sappro, Hokkaido
9.178.026 Boehringer Ingelheim Investigational Site
Higashi-osaka, Osaka
9.178.163 Boehringer Ingelheim Investigational Site
Higashidakawa-gun, Yamagata
9.178.120 Boehringer Ingelheim Investigational Site
Higashimatsushima, Miyagi
9.178.028 Boehringer Ingelheim Investigational Site
Higashinari-ku, Osaka, Osaka
9.178.140 Boehringer Ingelheim Investigational Site
Higashiosaka, Osaka
9.178.122 Boehringer Ingelheim Investigational Site
Higashisonogi-gun, Nagasaki
9.178.101 Boehringer Ingelheim Investigational Site
Higashiyodogawa-ku, Osaka, Osaka
9.178.093 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
9.178.153 Boehringer Ingelheim Investigational Site
Hitachi, Ibaraki
9.178.005 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
9.178.079 Boehringer Ingelheim Investigational Site
Ibusuki, Kagoshima
9.178.143 Boehringer Ingelheim Investigational Site
Ichikawa, Chiba
9.178.019 Boehringer Ingelheim Investigational Site
Iida, Nagano
9.178.129 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki
9.178.011 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
9.178.045 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
9.178.031 Boehringer Ingelheim Investigational Site
Itami, Hyogo
9.178.135 Boehringer Ingelheim Investigational Site
Iwanuma, Miyagi
9.178.104 Boehringer Ingelheim Investigational Site
Iwata, Shizuoka
9.178.095 Boehringer Ingelheim Investigational Site
Izuka, Fukuoka
9.178.080 Boehringer Ingelheim Investigational Site
Izumisano, Osaka
9.178.139 Boehringer Ingelheim Investigational Site
Izumo, Shimane
9.178.113 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka
9.178.115 Boehringer Ingelheim Investigational Site
Kahoku-gun, Ishikawa
9.178.147 Boehringer Ingelheim Investigational Site
Kameda-gun, Hokkaido
9.178.092 Boehringer Ingelheim Investigational Site
Kamigyo-ku, Kyoto, Kyoto
9.178.008 Boehringer Ingelheim Investigational Site
Kasama, Ibaraki
9.178.035 Boehringer Ingelheim Investigational Site
Kasuga, Fukuoka
9.178.037 Boehringer Ingelheim Investigational Site
Kasuga, Fukuoka
9.178.051 Boehringer Ingelheim Investigational Site
Kawachinagano, Osaka
9.178.086 Boehringer Ingelheim Investigational Site
Kisarazu, Chiba
9.178.162 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka
9.178.102 Boehringer Ingelheim Investigational Site
Kita-ku, Nagoya, Aichi
9.178.023 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Osaka
9.178.127 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Osaka
9.178.004 Boehringer Ingelheim Investigational Site
Kita-ku, Sappro, Hokkaido
9.178.154 Boehringer Ingelheim Investigational Site
Kitami, Hokkaido
9.178.155 Boehringer Ingelheim Investigational Site
Kitami, Hokkaido
9.178.069 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo
9.178.070 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo
9.178.121 Boehringer Ingelheim Investigational Site
Kochi, Kochi
9.178.141 Boehringer Ingelheim Investigational Site
Kochi, Kochi
9.178.061 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
9.178.085 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
9.178.075 Boehringer Ingelheim Investigational Site
Koshi, Kumamoto
9.178.107 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
9.178.063 Boehringer Ingelheim Investigational Site
Kushiro
9.178.083 Boehringer Ingelheim Investigational Site
Kushiro
9.178.126 Boehringer Ingelheim Investigational Site
Kushiro
9.178.150 Boehringer Ingelheim Investigational Site
Marugame, Kagawa
9.178.164 Boehringer Ingelheim Investigational Site
Matsudo, Chiba
9.178.015 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
9.178.130 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
9.178.057 Boehringer Ingelheim Investigational Site
Meito-ku, Nagoya, Aichi
9.178.013 Boehringer Ingelheim Investigational Site
Midori-ku, Yokohama, Kanagawa
9.178.043 Boehringer Ingelheim Investigational Site
Minami-ku, Hiroshima, Hiroshima
9.178.068 Boehringer Ingelheim Investigational Site
Miyagino-ku, Sendai, Miyagi
9.178.116 Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki
9.178.142 Boehringer Ingelheim Investigational Site
Moriguchi, Osaka
9.178.078 Boehringer Ingelheim Investigational Site
Morioka, Iwate
9.178.084 Boehringer Ingelheim Investigational Site
Morioka, Iwate
9.178.009 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
9.178.149 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
9.178.071 Boehringer Ingelheim Investigational Site
Musashimurayama, Tokyo
9.178.012 Boehringer Ingelheim Investigational Site
Musashino, Tokyo
9.178.100 Boehringer Ingelheim Investigational Site
Naka-ku, Hamamatsu, Shizuoka
9.178.110 Boehringer Ingelheim Investigational Site
Naka-ku, Hamamatsu, Shizuoka
9.178.020 Boehringer Ingelheim Investigational Site
Naka-ku, Nagoya, Aichi
9.178.053 Boehringer Ingelheim Investigational Site
Nakagawa-ku, Nagoya, Aichi
9.178.132 Boehringer Ingelheim Investigational Site
Nakagawa-ku, Nagoya, Nagoya
9.178.124 Boehringer Ingelheim Investigational Site
Namegata, Ibaraki
9.178.158 Boehringer Ingelheim Investigational Site
Nanao, Ishikawa
9.178.029 Boehringer Ingelheim Investigational Site
Nishi-yodogawa-ku, Osaka, Osaka
9.178.096 Boehringer Ingelheim Investigational Site
Nishisonogi-gun, Nagasaki
9.178.087 Boehringer Ingelheim Investigational Site
Noda, Chiba
9.178.058 Boehringer Ingelheim Investigational Site
Obu, Aichi
9.178.034 Boehringer Ingelheim Investigational Site
Ohnojo, Fukuoka
9.178.157 Boehringer Ingelheim Investigational Site
Okayama, Okayama
9.178.167 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
9.178.137 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
9.178.027 Boehringer Ingelheim Investigational Site
Sakai, Osaka
9.178.073 Boehringer Ingelheim Investigational Site
Sakai, Osaka
9.178.018 Boehringer Ingelheim Investigational Site
Saku, Nagano
9.178.160 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
9.178.041 Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo
9.178.088 Boehringer Ingelheim Investigational Site
Shibuya-ku, Tokyo
9.178.022 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto
9.178.076 Boehringer Ingelheim Investigational Site
Shimotsuke, Tochigi
9.178.055 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi
9.178.111 Boehringer Ingelheim Investigational Site
Simizu-ku, Shizuoka, Shizuoka
9.178.151 Boehringer Ingelheim Investigational Site
Suminoe-ku, Osaka, Osaka
9.178.156 Boehringer Ingelheim Investigational Site
Susono, Shizuoka
9.178.014 Boehringer Ingelheim Investigational Site
Suwa, Nagano
9.178.039 Boehringer Ingelheim Investigational Site
Takasaki, Gunma
9.178.146 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
9.178.144 Boehringer Ingelheim Investigational Site
Takayama, Gifu
9.178.003 Boehringer Ingelheim Investigational Site
Takikawa, Hokkaido
9.178.040 Boehringer Ingelheim Investigational Site
Tatebayashi, Gunma
9.178.066 Boehringer Ingelheim Investigational Site
Teine-ku, Sapporo, Hokkaido
9.178.134 Boehringer Ingelheim Investigational Site
Tenri, Nara
9.178.159 Boehringer Ingelheim Investigational Site
Tonami, Toyama
9.178.007 Boehringer Ingelheim Investigational Site
Toride, Ibaraki
9.178.047 Boehringer Ingelheim Investigational Site
Toyama, Toyama
9.178.090 Boehringer Ingelheim Investigational Site
Toyohashi, Aichi
9.178.131 Boehringer Ingelheim Investigational Site
Toyota, Aichi
9.178.006 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki
9.178.016 Boehringer Ingelheim Investigational Site
Ueda, Nagano
9.178.091 Boehringer Ingelheim Investigational Site
Uji, Kyoto
9.178.050 Boehringer Ingelheim Investigational Site
Ukyo-ku, Kyoto, Kyoto
9.178.106 Boehringer Ingelheim Investigational Site
Urayasu, Chiba
9.178.148 Boehringer Ingelheim Investigational Site
Wakayama, Wakayama
9.178.114 Boehringer Ingelheim Investigational Site
Wko, Saitama
9.178.152 Boehringer Ingelheim Investigational Site
Yaizu, Shizuoka
9.178.125 Boehringer Ingelheim Investigational Site
Yamashina, Kyoto, Kyoto
9.178.108 Boehringer Ingelheim Investigational Site
Yanai, Yamaguchi
9.178.103 Boehringer Ingelheim Investigational Site
Yao, Osaka

Other trials in Japan

About this study

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

Conditions: Cerebrovascular Accident
Being tested: Aggrenox capsule, Acetylsalicylic Acid (ASA)
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aggrenox capsuleDrug
extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
Acetylsalicylic Acid (ASA)Other
Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily

Study groups in NCT00311402
Study group	Role	What they receive
Aggrenox Capsule	Other	Not described Receives: Drug: Aggrenox capsule
Acetylsalicylic Acid (ASA) 81 mg Tablet	Other	Not described Receives: Other: Acetylsalicylic Acid (ASA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 124 weeks

Secondary outcomes (6)

Number of Patients With Brain (Cerebral) Haemorrhage
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Measured: Up to 124 weeks
Number of Patients With Subarachnoid Haemorrhage
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Measured: Up to 124 weeks
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.
Measured: Up to 124 weeks
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.
Measured: Up to 124 weeks
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.
Measured: Up to 124 weeks
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.
Measured: Up to 124 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Mar 2009

First posted6 Apr 2006 (estimated)
Study startApr 2006
Primary completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Intervention model: Parallel groups
Enrolment: 1,295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00311402
Sponsor's protocol ID: 9.178
Status last verified: Jan 2014
First submitted: 28 Mar 2006
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 21502757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebrovascular Accident trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00311402
Acronym / sponsor ID: 9.178
Conditions: Cerebrovascular Accident
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,295 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Mar 2009 (actual)
First posted: 6 Apr 2006 (estimated)
Results: Posted 11 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Aggrenox Capsule	Other	Drug: Aggrenox capsule
Acetylsalicylic Acid (ASA) 81 mg Tablet	Other	Other: Acetylsalicylic Acid (ASA)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aggrenox capsuleextended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily	Drug	Aggrenox Capsule
Acetylsalicylic Acid (ASA)Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily	Other	Acetylsalicylic Acid (ASA) 81 mg Tablet

Primary outcome

Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
Time frame: Up to 124 weeks
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

6 secondary outcomes

Number of Patients With Brain (Cerebral) Haemorrhage
Time frame: Up to 124 weeks
Number of Patients With Subarachnoid Haemorrhage
Time frame: Up to 124 weeks
Number of Patients With Transient Ischemic Attack (TIA)
Time frame: Up to 124 weeks
Number of Patients With Acute Coronary Syndrome (ACS)
Time frame: Up to 124 weeks
Number of Patients With Other Vascular Events
Time frame: Up to 124 weeks
Number of Patients With Ischemic Vascular Event Composite Endpoint
Time frame: Up to 124 weeks

Results and safety

Results posted to the registry on 11 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aggrenox Capsule	655	445
Acetylsalicylic Acid (ASA) 81 mg Tablet	639	462

Primary outcome: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)

Time frame: Up to 124 weeks. Number. Unit: patients

Measure	Aggrenox Capsule n = 652	Acetylsalicylic Acid (ASA) 81 mg Tablet n = 639
Value	45	32

Aggrenox Capsule vs Acetylsalicylic Acid (ASA) 81 mg Tablet: Cox Proportional Hazard: 1.47 (95% CI 0.93 to 2.31), p = 0.097, Regression, Cox

Population analysed: All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first drug dose until 6 days after last dose, up to 874 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aggrenox Capsule	178 of 655 (27.2%)	634 of 655 (96.8%)	Not reported
Acetylsalicylic Acid (ASA) 81 mg Tablet	167 of 639 (26.1%)	604 of 639 (94.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21502757Uchiyama 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.
Related InfoLink provided by the sponsor.

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Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

151 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aggrenox capsule and Acetylsalicylic Acid (ASA) in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 151 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (time frame: Up to 124 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00311402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.