JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00311402
Collaborator
(none)
1,295
151
2
8.6
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1295 participants
Intervention Model:
Parallel Assignment
Primary Purpose:
Prevention
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 Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Aggrenox Capsule
|
Drug: Aggrenox capsule
extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
|
| Other: Acetylsalicylic Acid (ASA) 81 mg Tablet
|
Other: Acetylsalicylic Acid (ASA)
Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) [Up to 124 weeks]
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Secondary Outcome Measures
- Number of Patients With Brain (Cerebral) Haemorrhage [Up to 124 weeks]
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
- Number of Patients With Subarachnoid Haemorrhage [Up to 124 weeks]
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
- Number of Patients With Transient Ischemic Attack (TIA) [Up to 124 weeks]
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
- Number of Patients With Acute Coronary Syndrome (ACS) [Up to 124 weeks]
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.
- Number of Patients With Other Vascular Events [Up to 124 weeks]
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.
- Number of Patients With Ischemic Vascular Event Composite Endpoint [Up to 124 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 9.178.060 Boehringer Ingelheim Investigational Site | Adachi-ku, Tokyo | Japan | ||
| 2 | 9.178.017 Boehringer Ingelheim Investigational Site | Adumino, Nagano | Japan | ||
| 3 | 9.178.032 Boehringer Ingelheim Investigational Site | Akashi, Hyogo | Japan | ||
| 4 | 9.178.074 Boehringer Ingelheim Investigational Site | Akashi, Hyogo | Japan | ||
| 5 | 9.178.062 Boehringer Ingelheim Investigational Site | Ako, Hyogo | Japan | ||
| 6 | 9.178.064 Boehringer Ingelheim Investigational Site | Aoba-ku, Yokohama, Kanagawa | Japan | ||
| 7 | 9.178.097 Boehringer Ingelheim Investigational Site | Aoi-ku, Shizuoka, Shizuoka | Japan | ||
| 8 | 9.178.056 Boehringer Ingelheim Investigational Site | Asahi, Chiba | Japan | ||
| 9 | 9.178.067 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | Japan | ||
| 10 | 9.178.117 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | Japan | ||
| 11 | 9.178.166 Boehringer Ingelheim Investigational Site | Atsugi, Kanagawa | Japan | ||
| 12 | 9.178.089 Boehringer Ingelheim Investigational Site | Bunkyo-ku, Tokyo | Japan | ||
| 13 | 9.178.054 Boehringer Ingelheim Investigational Site | Chitose, Hokkaido | Japan | ||
| 14 | 9.178.133 Boehringer Ingelheim Investigational Site | Chuo-ku, Chiba, Chiba | Japan | ||
| 15 | 9.178.030 Boehringer Ingelheim Investigational Site | Chuo-ku, Kobe, Hyogo | Japan | ||
| 16 | 9.178.077 Boehringer Ingelheim Investigational Site | Chuo-ku, Sapporo, Hokkaido | Japan | ||
| 17 | 9.178.002 Boehringer Ingelheim Investigational Site | Chuo-Ku, Sappro, Hokkaido | Japan | ||
| 18 | 9.178.119 Boehringer Ingelheim Investigational Site | Chuo-ku, Sappro, Hokkaido | Japan | ||
| 19 | 9.178.161 Boehringer Ingelheim Investigational Site | Daito, Osaka | Japan | ||
| 20 | 9.178.112 Boehringer Ingelheim Investigational Site | Fuchu, Tokyo | Japan | ||
| 21 | 9.178.098 Boehringer Ingelheim Investigational Site | Fujieda, Shizuoka | Japan | ||
| 22 | 9.178.046 Boehringer Ingelheim Investigational Site | Fukaya, Saitama | Japan | ||
| 23 | 9.178.145 Boehringer Ingelheim Investigational Site | Fukui, Fukui | Japan | ||
| 24 | 9.178.099 Boehringer Ingelheim Investigational Site | Fukuroi, Shizuoka | Japan | ||
| 25 | 9.178.165 Boehringer Ingelheim Investigational Site | Funabashi, Chiba | Japan | ||
| 26 | 9.178.072 Boehringer Ingelheim Investigational Site | Fushimi-ku, Kyoto, Kyoto | Japan | ||
| 27 | 9.178.081 Boehringer Ingelheim Investigational Site | Gifu, Gifu | Japan | ||
| 28 | 9.178.024 Boehringer Ingelheim Investigational Site | Habikino, Osaka | Japan | ||
| 29 | 9.178.136 Boehringer Ingelheim Investigational Site | Hachioji, Tokyo | Japan | ||
| 30 | 9.178.082 Boehringer Ingelheim Investigational Site | Hakodate, Hokkaido | Japan | ||
| 31 | 9.178.118 Boehringer Ingelheim Investigational Site | Hakodate, Hokkaido | Japan | ||
| 32 | 9.178.052 Boehringer Ingelheim Investigational Site | Hamada, Shimane | Japan | ||
| 33 | 9.178.138 Boehringer Ingelheim Investigational Site | Hashima-gun, Gifu | Japan | ||
| 34 | 9.178.169 Boehringer Ingelheim Investigational Site | Hidaka, Saitama | Japan | ||
| 35 | 9.178.001 Boehringer Ingelheim Investigational Site | Higashi-ku, Sappro, Hokkaido | Japan | ||
| 36 | 9.178.026 Boehringer Ingelheim Investigational Site | Higashi-osaka, Osaka | Japan | ||
| 37 | 9.178.163 Boehringer Ingelheim Investigational Site | Higashidakawa-gun, Yamagata | Japan | ||
| 38 | 9.178.120 Boehringer Ingelheim Investigational Site | Higashimatsushima, Miyagi | Japan | ||
| 39 | 9.178.028 Boehringer Ingelheim Investigational Site | Higashinari-ku, Osaka, Osaka | Japan | ||
| 40 | 9.178.140 Boehringer Ingelheim Investigational Site | Higashiosaka, Osaka | Japan | ||
| 41 | 9.178.122 Boehringer Ingelheim Investigational Site | Higashisonogi-gun, Nagasaki | Japan | ||
| 42 | 9.178.101 Boehringer Ingelheim Investigational Site | Higashiyodogawa-ku, Osaka, Osaka | Japan | ||
| 43 | 9.178.093 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan | ||
| 44 | 9.178.153 Boehringer Ingelheim Investigational Site | Hitachi, Ibaraki | Japan | ||
| 45 | 9.178.005 Boehringer Ingelheim Investigational Site | Hitachinaka, Ibaraki | Japan | ||
| 46 | 9.178.079 Boehringer Ingelheim Investigational Site | Ibusuki, Kagoshima | Japan | ||
| 47 | 9.178.143 Boehringer Ingelheim Investigational Site | Ichikawa, Chiba | Japan | ||
| 48 | 9.178.019 Boehringer Ingelheim Investigational Site | Iida, Nagano | Japan | ||
| 49 | 9.178.129 Boehringer Ingelheim Investigational Site | Inashiki-gun, Ibaraki | Japan | ||
| 50 | 9.178.011 Boehringer Ingelheim Investigational Site | Isesaki, Gunma | Japan | ||
| 51 | 9.178.045 Boehringer Ingelheim Investigational Site | Isesaki, Gunma | Japan | ||
| 52 | 9.178.031 Boehringer Ingelheim Investigational Site | Itami, Hyogo | Japan | ||
| 53 | 9.178.135 Boehringer Ingelheim Investigational Site | Iwanuma, Miyagi | Japan | ||
| 54 | 9.178.104 Boehringer Ingelheim Investigational Site | Iwata, Shizuoka | Japan | ||
| 55 | 9.178.095 Boehringer Ingelheim Investigational Site | Izuka, Fukuoka | Japan | ||
| 56 | 9.178.080 Boehringer Ingelheim Investigational Site | Izumisano, Osaka | Japan | ||
| 57 | 9.178.139 Boehringer Ingelheim Investigational Site | Izumo, Shimane | Japan | ||
| 58 | 9.178.113 Boehringer Ingelheim Investigational Site | Izunokuni, Shizuoka | Japan | ||
| 59 | 9.178.115 Boehringer Ingelheim Investigational Site | Kahoku-gun, Ishikawa | Japan | ||
| 60 | 9.178.147 Boehringer Ingelheim Investigational Site | Kameda-gun, Hokkaido | Japan | ||
| 61 | 9.178.092 Boehringer Ingelheim Investigational Site | Kamigyo-ku, Kyoto, Kyoto | Japan | ||
| 62 | 9.178.008 Boehringer Ingelheim Investigational Site | Kasama, Ibaraki | Japan | ||
| 63 | 9.178.035 Boehringer Ingelheim Investigational Site | Kasuga, Fukuoka | Japan | ||
| 64 | 9.178.037 Boehringer Ingelheim Investigational Site | Kasuga, Fukuoka | Japan | ||
| 65 | 9.178.051 Boehringer Ingelheim Investigational Site | Kawachinagano, Osaka | Japan | ||
| 66 | 9.178.086 Boehringer Ingelheim Investigational Site | Kisarazu, Chiba | Japan | ||
| 67 | 9.178.162 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | Japan | ||
| 68 | 9.178.102 Boehringer Ingelheim Investigational Site | Kita-ku, Nagoya, Aichi | Japan | ||
| 69 | 9.178.023 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka, Osaka | Japan | ||
| 70 | 9.178.127 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka, Osaka | Japan | ||
| 71 | 9.178.004 Boehringer Ingelheim Investigational Site | Kita-ku, Sappro, Hokkaido | Japan | ||
| 72 | 9.178.154 Boehringer Ingelheim Investigational Site | Kitami, Hokkaido | Japan | ||
| 73 | 9.178.155 Boehringer Ingelheim Investigational Site | Kitami, Hokkaido | Japan | ||
| 74 | 9.178.069 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | Japan | ||
| 75 | 9.178.070 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | Japan | ||
| 76 | 9.178.121 Boehringer Ingelheim Investigational Site | Kochi, Kochi | Japan | ||
| 77 | 9.178.141 Boehringer Ingelheim Investigational Site | Kochi, Kochi | Japan | ||
| 78 | 9.178.061 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan | ||
| 79 | 9.178.085 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan | ||
| 80 | 9.178.075 Boehringer Ingelheim Investigational Site | Koshi, Kumamoto | Japan | ||
| 81 | 9.178.107 Boehringer Ingelheim Investigational Site | Kurashiki, Okayama | Japan | ||
| 82 | 9.178.063 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | Japan | ||
| 83 | 9.178.083 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | Japan | ||
| 84 | 9.178.126 Boehringer Ingelheim Investigational Site | Kushiro, Hokkaido | Japan | ||
| 85 | 9.178.150 Boehringer Ingelheim Investigational Site | Marugame, Kagawa | Japan | ||
| 86 | 9.178.164 Boehringer Ingelheim Investigational Site | Matsudo, Chiba | Japan | ||
| 87 | 9.178.015 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano | Japan | ||
| 88 | 9.178.130 Boehringer Ingelheim Investigational Site | Meguro-ku, Tokyo | Japan | ||
| 89 | 9.178.057 Boehringer Ingelheim Investigational Site | Meito-ku, Nagoya, Aichi | Japan | ||
| 90 | 9.178.013 Boehringer Ingelheim Investigational Site | Midori-ku, Yokohama, Kanagawa | Japan | ||
| 91 | 9.178.043 Boehringer Ingelheim Investigational Site | Minami-ku, Hiroshima, Hiroshima | Japan | ||
| 92 | 9.178.068 Boehringer Ingelheim Investigational Site | Miyagino-ku, Sendai, Miyagi | Japan | ||
| 93 | 9.178.116 Boehringer Ingelheim Investigational Site | Miyazaki, Miyazaki | Japan | ||
| 94 | 9.178.142 Boehringer Ingelheim Investigational Site | Moriguchi, Osaka | Japan | ||
| 95 | 9.178.078 Boehringer Ingelheim Investigational Site | Morioka, Iwate | Japan | ||
| 96 | 9.178.084 Boehringer Ingelheim Investigational Site | Morioka, Iwate | Japan | ||
| 97 | 9.178.009 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki | Japan | ||
| 98 | 9.178.149 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki | Japan | ||
| 99 | 9.178.071 Boehringer Ingelheim Investigational Site | Musashimurayama, Tokyo | Japan | ||
| 100 | 9.178.012 Boehringer Ingelheim Investigational Site | Musashino, Tokyo | Japan | ||
| 101 | 9.178.100 Boehringer Ingelheim Investigational Site | Naka-ku, Hamamatsu, Shizuoka | Japan | ||
| 102 | 9.178.110 Boehringer Ingelheim Investigational Site | Naka-ku, Hamamatsu, Shizuoka | Japan | ||
| 103 | 9.178.020 Boehringer Ingelheim Investigational Site | Naka-ku, Nagoya, Aichi | Japan | ||
| 104 | 9.178.053 Boehringer Ingelheim Investigational Site | Nakagawa-ku, Nagoya, Aichi | Japan | ||
| 105 | 9.178.132 Boehringer Ingelheim Investigational Site | Nakagawa-ku, Nagoya, Nagoya | Japan | ||
| 106 | 9.178.124 Boehringer Ingelheim Investigational Site | Namegata, Ibaraki | Japan | ||
| 107 | 9.178.158 Boehringer Ingelheim Investigational Site | Nanao, Ishikawa | Japan | ||
| 108 | 9.178.029 Boehringer Ingelheim Investigational Site | Nishi-yodogawa-ku, Osaka, Osaka | Japan | ||
| 109 | 9.178.096 Boehringer Ingelheim Investigational Site | Nishisonogi-gun, Nagasaki | Japan | ||
| 110 | 9.178.087 Boehringer Ingelheim Investigational Site | Noda, Chiba | Japan | ||
| 111 | 9.178.058 Boehringer Ingelheim Investigational Site | Obu, Aichi | Japan | ||
| 112 | 9.178.034 Boehringer Ingelheim Investigational Site | Ohnojo, Fukuoka | Japan | ||
| 113 | 9.178.157 Boehringer Ingelheim Investigational Site | Okayama, Okayama | Japan | ||
| 114 | 9.178.167 Boehringer Ingelheim Investigational Site | Okinawa, Okinawa | Japan | ||
| 115 | 9.178.137 Boehringer Ingelheim Investigational Site | Sagamihara, Kanagawa | Japan | ||
| 116 | 9.178.027 Boehringer Ingelheim Investigational Site | Sakai, Osaka | Japan | ||
| 117 | 9.178.073 Boehringer Ingelheim Investigational Site | Sakai, Osaka | Japan | ||
| 118 | 9.178.018 Boehringer Ingelheim Investigational Site | Saku, Nagano | Japan | ||
| 119 | 9.178.160 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan | ||
| 120 | 9.178.041 Boehringer Ingelheim Investigational Site | Setagaya-ku, Tokyo | Japan | ||
| 121 | 9.178.088 Boehringer Ingelheim Investigational Site | Shibuya-ku, Tokyo | Japan | ||
| 122 | 9.178.022 Boehringer Ingelheim Investigational Site | Shimogyo-ku, Kyoto, Kyoto | Japan | ||
| 123 | 9.178.076 Boehringer Ingelheim Investigational Site | Shimotsuke, Tochigi | Japan | ||
| 124 | 9.178.055 Boehringer Ingelheim Investigational Site | Shiroishi, Miyagi | Japan | ||
| 125 | 9.178.111 Boehringer Ingelheim Investigational Site | Simizu-ku, Shizuoka, Shizuoka | Japan | ||
| 126 | 9.178.151 Boehringer Ingelheim Investigational Site | Suminoe-ku, Osaka, Osaka | Japan | ||
| 127 | 9.178.156 Boehringer Ingelheim Investigational Site | Susono, Shizuoka | Japan | ||
| 128 | 9.178.014 Boehringer Ingelheim Investigational Site | Suwa, Nagano | Japan | ||
| 129 | 9.178.039 Boehringer Ingelheim Investigational Site | Takasaki, Gunma | Japan | ||
| 130 | 9.178.146 Boehringer Ingelheim Investigational Site | Takatsuki, Osaka | Japan | ||
| 131 | 9.178.144 Boehringer Ingelheim Investigational Site | Takayama, Gifu | Japan | ||
| 132 | 9.178.003 Boehringer Ingelheim Investigational Site | Takikawa, Hokkaido | Japan | ||
| 133 | 9.178.040 Boehringer Ingelheim Investigational Site | Tatebayashi, Gunma | Japan | ||
| 134 | 9.178.066 Boehringer Ingelheim Investigational Site | Teine-ku, Sapporo, Hokkaido | Japan | ||
| 135 | 9.178.134 Boehringer Ingelheim Investigational Site | Tenri, Nara | Japan | ||
| 136 | 9.178.159 Boehringer Ingelheim Investigational Site | Tonami, Toyama | Japan | ||
| 137 | 9.178.007 Boehringer Ingelheim Investigational Site | Toride, Ibaraki | Japan | ||
| 138 | 9.178.047 Boehringer Ingelheim Investigational Site | Toyama, Toyama | Japan | ||
| 139 | 9.178.090 Boehringer Ingelheim Investigational Site | Toyohashi, Aichi | Japan | ||
| 140 | 9.178.131 Boehringer Ingelheim Investigational Site | Toyota, Aichi | Japan | ||
| 141 | 9.178.006 Boehringer Ingelheim Investigational Site | Tsuchiura, Ibaraki | Japan | ||
| 142 | 9.178.016 Boehringer Ingelheim Investigational Site | Ueda, Nagano | Japan | ||
| 143 | 9.178.091 Boehringer Ingelheim Investigational Site | Uji, Kyoto | Japan | ||
| 144 | 9.178.050 Boehringer Ingelheim Investigational Site | Ukyo-ku, Kyoto, Kyoto | Japan | ||
| 145 | 9.178.106 Boehringer Ingelheim Investigational Site | Urayasu, Chiba | Japan | ||
| 146 | 9.178.148 Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | Japan | ||
| 147 | 9.178.114 Boehringer Ingelheim Investigational Site | Wko, Saitama | Japan | ||
| 148 | 9.178.152 Boehringer Ingelheim Investigational Site | Yaizu, Shizuoka | Japan | ||
| 149 | 9.178.125 Boehringer Ingelheim Investigational Site | Yamashina, Kyoto, Kyoto | Japan | ||
| 150 | 9.178.108 Boehringer Ingelheim Investigational Site | Yanai, Yamaguchi | Japan | ||
| 151 | 9.178.103 Boehringer Ingelheim Investigational Site | Yao, Osaka | Japan |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00311402
Other Study ID Numbers:
- 9.178
First Posted:
Apr 6, 2006
Last Update Posted:
Feb 14, 2014
Last Verified:
Jan 1, 2014
Study Results
Participant Flow
| Recruitment Details | Patient recruitment initiated from June 2006 and completed in December 2007. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Period Title: Overall Study | ||
| STARTED | 655 | 639 |
| COMPLETED | 445 | 462 |
| NOT COMPLETED | 210 | 177 |
Baseline Characteristics
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet | Total |
|---|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily | Total of all reporting groups |
| Overall Participants | 655 | 639 | 1294 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.2
(8.1)
|
66.0
(8.6)
|
66.1
(8.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
183
27.9%
|
186
29.1%
|
369
28.5%
|
| Male |
472
72.1%
|
453
70.9%
|
925
71.5%
|
Outcome Measures
| Title | Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) |
|---|---|
| Description | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
45
|
32
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power. | |
| Statistical Test of Hypothesis | p-Value | 0.097 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.47 | |
| Confidence Interval |
() 95% 0.93 to 2.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Brain (Cerebral) Haemorrhage |
|---|---|
| Description | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
12
|
7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.223 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.79 | |
| Confidence Interval |
() 95% 0.70 to 4.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Subarachnoid Haemorrhage |
|---|---|
| Description | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
0
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.998 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0 | |
| Confidence Interval |
(1-Sided) 95% 0 to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Transient Ischemic Attack (TIA) |
|---|---|
| Description | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
3
|
3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.977 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.02 | |
| Confidence Interval |
() 95% 0.21 to 5.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Acute Coronary Syndrome (ACS) |
|---|---|
| Description | 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. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
9
|
16
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.192 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.58 | |
| Confidence Interval |
() 95% 0.26 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Other Vascular Events |
|---|---|
| Description | 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. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
11
|
6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.215 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.88 | |
| Confidence Interval |
() 95% 0.69 to 5.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Ischemic Vascular Event Composite Endpoint |
|---|---|
| Description | 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. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
57
|
51
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.443 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.16 | |
| Confidence Interval |
() 95% 0.79 to 1.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Stroke |
|---|---|
| Description | This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
57
|
39
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.52 | |
| Confidence Interval |
() 95% 1.01 to 2.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Intracranial Haemorrhage |
|---|---|
| Description | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
13
|
13
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.04 | |
| Confidence Interval |
() 95% 0.48 to 2.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With Composite Endpoint of Stroke or Major Bleeding |
|---|---|
| Description | This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Time Frame | Up to 124 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily |
| Measure Participants | 652 | 639 |
| Number [patients] |
71
|
55
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aggrenox Capsule, Acetylsalicylic Acid (ASA) 81 mg Tablet |
|---|---|---|
| Comments | Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.101 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.34 | |
| Confidence Interval |
() 95% 0.94 to 1.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From day of first drug dose until 6 days after last dose, up to 874 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet | ||
| Arm/Group Description | Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily | ASA 81 mg, 1 tablet once daily | ||
All Cause Mortality |
||||
| Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 178/655 (27.2%) | 167/639 (26.1%) | ||
| Blood and lymphatic system disorders | ||||
| Iron deficiency anaemia | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Neutropenia | 0/655 (0%) | 1/639 (0.2%) | ||
| Cardiac disorders | ||||
| Angina unstable | 1/655 (0.2%) | 6/639 (0.9%) | ||
| Angina pectoris | 5/655 (0.8%) | 4/639 (0.6%) | ||
| Myocardial infarction | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Acute myocardial infarction | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Atrial fibrillation | 0/655 (0%) | 1/639 (0.2%) | ||
| Cardiac failure acute | 0/655 (0%) | 1/639 (0.2%) | ||
| Cardiac failure congestive | 0/655 (0%) | 1/639 (0.2%) | ||
| Cardio-respiratory arrest | 1/655 (0.2%) | 0/639 (0%) | ||
| Ischaemic cardiomyopathy | 0/655 (0%) | 1/639 (0.2%) | ||
| Myocardial ischaemia | 0/655 (0%) | 1/639 (0.2%) | ||
| Right ventricular failure | 1/655 (0.2%) | 0/639 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/655 (0.2%) | 2/639 (0.3%) | ||
| Vertigo positional | 0/655 (0%) | 2/639 (0.3%) | ||
| Auricular perichondritis | 0/655 (0%) | 1/639 (0.2%) | ||
| Vertigo labyrinthine | 1/655 (0.2%) | 0/639 (0%) | ||
| Endocrine disorders | ||||
| Hyperadrenalism | 1/655 (0.2%) | 0/639 (0%) | ||
| Eye disorders | ||||
| Cataract | 3/655 (0.5%) | 6/639 (0.9%) | ||
| Maculopathy | 0/655 (0%) | 2/639 (0.3%) | ||
| Eyelid ptosis | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Retinal artery occlusion | 1/655 (0.2%) | 0/639 (0%) | ||
| Retinal detachment | 0/655 (0%) | 1/639 (0.2%) | ||
| Retinal vein occlusion | 1/655 (0.2%) | 0/639 (0%) | ||
| Vitreous haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| Gastrointestinal disorders | ||||
| Colonic polyp | 11/655 (1.7%) | 8/639 (1.3%) | ||
| Inguinal hernia | 1/655 (0.2%) | 4/639 (0.6%) | ||
| Gastric ulcer haemorrhage | 3/655 (0.5%) | 2/639 (0.3%) | ||
| Gastrointestinal haemorrhage | 2/655 (0.3%) | 3/639 (0.5%) | ||
| Vomiting | 0/655 (0%) | 2/639 (0.3%) | ||
| Acute abdomen | 0/655 (0%) | 1/639 (0.2%) | ||
| Colitis | 0/655 (0%) | 1/639 (0.2%) | ||
| Colitis ischaemic | 0/655 (0%) | 1/639 (0.2%) | ||
| Colitis ulcerative | 0/655 (0%) | 1/639 (0.2%) | ||
| Constipation | 0/655 (0%) | 1/639 (0.2%) | ||
| Diarrhoea | 0/655 (0%) | 1/639 (0.2%) | ||
| Diverticulum intestinal haemorrhagic | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Gastric polyps | 0/655 (0%) | 1/639 (0.2%) | ||
| Gastric ulcer | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Gastritis | 0/655 (0%) | 1/639 (0.2%) | ||
| Gastritis atrophic | 0/655 (0%) | 1/639 (0.2%) | ||
| Gastritis haemorrhagic | 1/655 (0.2%) | 0/639 (0%) | ||
| Haematemesis | 0/655 (0%) | 1/639 (0.2%) | ||
| Intestinal ischaemia | 0/655 (0%) | 1/639 (0.2%) | ||
| Mallory-Weiss syndrome | 0/655 (0%) | 1/639 (0.2%) | ||
| Oesophageal haemorrhage | 0/655 (0%) | 1/639 (0.2%) | ||
| Oesophageal rupture | 0/655 (0%) | 1/639 (0.2%) | ||
| Oesophageal ulcer | 0/655 (0%) | 1/639 (0.2%) | ||
| Oesophagitis haemorrhagic | 0/655 (0%) | 1/639 (0.2%) | ||
| Rectal haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| Subileus | 0/655 (0%) | 1/639 (0.2%) | ||
| Upper gastrointestinal haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| General disorders | ||||
| Sudden death | 1/655 (0.2%) | 4/639 (0.6%) | ||
| Multi-organ failure | 0/655 (0%) | 2/639 (0.3%) | ||
| Chest pain | 1/655 (0.2%) | 0/639 (0%) | ||
| Implant site inflammation | 1/655 (0.2%) | 0/639 (0%) | ||
| Mass | 0/655 (0%) | 1/639 (0.2%) | ||
| Non-cardiac chest pain | 0/655 (0%) | 1/639 (0.2%) | ||
| Oedema due to renal disease | 0/655 (0%) | 1/639 (0.2%) | ||
| Pain | 0/655 (0%) | 1/639 (0.2%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/655 (0%) | 2/639 (0.3%) | ||
| Cholelithiasis | 1/655 (0.2%) | 0/639 (0%) | ||
| Gallbladder polyp | 1/655 (0.2%) | 0/639 (0%) | ||
| Hepatic cirrhosis | 1/655 (0.2%) | 0/639 (0%) | ||
| Hepatitis acute | 1/655 (0.2%) | 0/639 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 2/655 (0.3%) | 3/639 (0.5%) | ||
| Urinary tract infection | 2/655 (0.3%) | 0/639 (0%) | ||
| Acute tonsillitis | 0/655 (0%) | 1/639 (0.2%) | ||
| Bronchopulmonary aspergillosis allergic | 0/655 (0%) | 1/639 (0.2%) | ||
| Cellulitis | 0/655 (0%) | 1/639 (0.2%) | ||
| Diverticulitis | 0/655 (0%) | 1/639 (0.2%) | ||
| Gangrene | 1/655 (0.2%) | 0/639 (0%) | ||
| Peritonsillar abscess | 0/655 (0%) | 1/639 (0.2%) | ||
| Pleurisy viral | 1/655 (0.2%) | 0/639 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Spinal compression fracture | 1/655 (0.2%) | 4/639 (0.6%) | ||
| Subdural haematoma | 0/655 (0%) | 4/639 (0.6%) | ||
| Contusion | 1/655 (0.2%) | 3/639 (0.5%) | ||
| Femoral neck fracture | 1/655 (0.2%) | 3/639 (0.5%) | ||
| Femur fracture | 1/655 (0.2%) | 3/639 (0.5%) | ||
| Cerebral haemorrhage traumatic | 2/655 (0.3%) | 0/639 (0%) | ||
| Foot fracture | 2/655 (0.3%) | 0/639 (0%) | ||
| Meniscus lesion | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Rib fracture | 2/655 (0.3%) | 0/639 (0%) | ||
| Road traffic accident | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Ankle fracture | 1/655 (0.2%) | 0/639 (0%) | ||
| Blast injury | 1/655 (0.2%) | 0/639 (0%) | ||
| Brain contusion | 1/655 (0.2%) | 0/639 (0%) | ||
| Burns first degree | 1/655 (0.2%) | 0/639 (0%) | ||
| Burns second degree | 1/655 (0.2%) | 0/639 (0%) | ||
| Clavicle fracture | 0/655 (0%) | 1/639 (0.2%) | ||
| Diffuse axonal injury | 1/655 (0.2%) | 0/639 (0%) | ||
| Excoriation | 0/655 (0%) | 1/639 (0.2%) | ||
| Facial bones fracture | 1/655 (0.2%) | 0/639 (0%) | ||
| Fat embolism | 0/655 (0%) | 1/639 (0.2%) | ||
| Head injury | 0/655 (0%) | 1/639 (0.2%) | ||
| Hip fracture | 1/655 (0.2%) | 0/639 (0%) | ||
| Humerus fracture | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Joint dislocation | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Limb traumatic amputation | 0/655 (0%) | 1/639 (0.2%) | ||
| Neck injury | 1/655 (0.2%) | 0/639 (0%) | ||
| Pubic rami fracture | 1/655 (0.2%) | 0/639 (0%) | ||
| Scapula fracture | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Skin laceration | 0/655 (0%) | 1/639 (0.2%) | ||
| Subdural haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| Tibia fracture | 0/655 (0%) | 1/639 (0.2%) | ||
| Investigations | ||||
| Prostatic specific antigen increased | 0/655 (0%) | 1/639 (0.2%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus inadequate control | 3/655 (0.5%) | 2/639 (0.3%) | ||
| Dehydration | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Diabetes mellitus | 1/655 (0.2%) | 2/639 (0.3%) | ||
| Anorexia | 1/655 (0.2%) | 0/639 (0%) | ||
| Hyperglycaemia | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Hyponatraemia | 0/655 (0%) | 1/639 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Cervical spinal stenosis | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Dupuytren's contracture | 0/655 (0%) | 1/639 (0.2%) | ||
| Foot deformity | 0/655 (0%) | 1/639 (0.2%) | ||
| Intervertebral disc protrusion | 0/655 (0%) | 1/639 (0.2%) | ||
| Lumbar spinal stenosis | 1/655 (0.2%) | 0/639 (0%) | ||
| Muscle spasms | 1/655 (0.2%) | 0/639 (0%) | ||
| Osteoarthritis | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Rhabdomyolysis | 1/655 (0.2%) | 0/639 (0%) | ||
| Rotator cuff syndrome | 1/655 (0.2%) | 0/639 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Colon cancer | 4/655 (0.6%) | 4/639 (0.6%) | ||
| Prostate cancer | 3/655 (0.5%) | 4/639 (0.6%) | ||
| Hepatic neoplasm malignant | 3/655 (0.5%) | 0/639 (0%) | ||
| Large intestine carcinoma | 3/655 (0.5%) | 0/639 (0%) | ||
| Bladder cancer | 1/655 (0.2%) | 2/639 (0.3%) | ||
| Colon adenoma | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Gastric cancer | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Rectal cancer | 2/655 (0.3%) | 1/639 (0.2%) | ||
| Adenocarcinoma | 1/655 (0.2%) | 0/639 (0%) | ||
| Breast cancer | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Gastrointestinal stromal tumour | 1/655 (0.2%) | 0/639 (0%) | ||
| Intestinal adenocarcinoma | 1/655 (0.2%) | 0/639 (0%) | ||
| Laryngeal cancer | 1/655 (0.2%) | 0/639 (0%) | ||
| Leiomyosarcoma | 1/655 (0.2%) | 0/639 (0%) | ||
| Lung cancer metastatic | 0/655 (0%) | 1/639 (0.2%) | ||
| Malignant pleural effusion | 1/655 (0.2%) | 0/639 (0%) | ||
| Neoplasm progression | 1/655 (0.2%) | 0/639 (0%) | ||
| Oesophageal carcinoma | 1/655 (0.2%) | 0/639 (0%) | ||
| Ovarian cancer | 1/655 (0.2%) | 0/639 (0%) | ||
| Ovarian neoplasm | 0/655 (0%) | 1/639 (0.2%) | ||
| Rectosigmoid cancer | 1/655 (0.2%) | 0/639 (0%) | ||
| Renal cancer | 1/655 (0.2%) | 0/639 (0%) | ||
| Salivary gland neoplasm | 1/655 (0.2%) | 0/639 (0%) | ||
| Small cell lung cancer stage unspecified | 1/655 (0.2%) | 0/639 (0%) | ||
| Nervous system disorders | ||||
| Cerebral infarction | 46/655 (7%) | 32/639 (5%) | ||
| Cerebral haemorrhage | 5/655 (0.8%) | 2/639 (0.3%) | ||
| Cerebellar haemorrhage | 4/655 (0.6%) | 1/639 (0.2%) | ||
| Dizziness | 2/655 (0.3%) | 3/639 (0.5%) | ||
| Thalamus haemorrhage | 2/655 (0.3%) | 3/639 (0.5%) | ||
| Epilepsy | 2/655 (0.3%) | 0/639 (0%) | ||
| Subarachnoid haemorrhage | 0/655 (0%) | 2/639 (0.3%) | ||
| Transient ischaemic attack | 2/655 (0.3%) | 0/639 (0%) | ||
| Basilar migraine | 1/655 (0.2%) | 0/639 (0%) | ||
| Carotid artery stenosis | 0/655 (0%) | 1/639 (0.2%) | ||
| Cerebellar infarction | 1/655 (0.2%) | 0/639 (0%) | ||
| Cerebrovascular accident | 1/655 (0.2%) | 0/639 (0%) | ||
| Haemorrhagic cerebral infarction | 0/655 (0%) | 1/639 (0.2%) | ||
| Hypertensive encephalopathy | 0/655 (0%) | 1/639 (0.2%) | ||
| Loss of consciousness | 0/655 (0%) | 1/639 (0.2%) | ||
| Mental impairment | 1/655 (0.2%) | 0/639 (0%) | ||
| Nystagmus | 0/655 (0%) | 1/639 (0.2%) | ||
| Putamen haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| Spondylitic myelopathy | 0/655 (0%) | 1/639 (0.2%) | ||
| Psychiatric disorders | ||||
| Depression | 2/655 (0.3%) | 0/639 (0%) | ||
| Anxiety disorder | 0/655 (0%) | 1/639 (0.2%) | ||
| Completed suicide | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Schizophrenia | 0/655 (0%) | 1/639 (0.2%) | ||
| Renal and urinary disorders | ||||
| Calculus bladder | 1/655 (0.2%) | 0/639 (0%) | ||
| Diabetic nephropathy | 1/655 (0.2%) | 0/639 (0%) | ||
| Renal failure chronic | 1/655 (0.2%) | 1/639 (0.2%) | ||
| Renal impairment | 1/655 (0.2%) | 0/639 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/655 (0.2%) | 2/639 (0.3%) | ||
| Pelvic haemorrhage | 1/655 (0.2%) | 0/639 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/655 (0%) | 1/639 (0.2%) | ||
| Asthma | 1/655 (0.2%) | 0/639 (0%) | ||
| Chronic obstructive pulmonary disease | 1/655 (0.2%) | 0/639 (0%) | ||
| Epistaxis | 1/655 (0.2%) | 0/639 (0%) | ||
| Haemothorax | 1/655 (0.2%) | 0/639 (0%) | ||
| Hyperventilation | 1/655 (0.2%) | 0/639 (0%) | ||
| Pleural effusion | 1/655 (0.2%) | 0/639 (0%) | ||
| Pneumonia aspiration | 0/655 (0%) | 1/639 (0.2%) | ||
| Sleep apnoea syndrome | 1/655 (0.2%) | 0/639 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Drug eruption | 1/655 (0.2%) | 0/639 (0%) | ||
| Hypoaesthesia facial | 1/655 (0.2%) | 0/639 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 0/655 (0%) | 1/639 (0.2%) | ||
| Aortic aneurysm rupture | 0/655 (0%) | 1/639 (0.2%) | ||
| Shock haemorrhagic | 0/655 (0%) | 1/639 (0.2%) | ||
| Thrombophlebitis | 1/655 (0.2%) | 0/639 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Aggrenox Capsule | Acetylsalicylic Acid (ASA) 81 mg Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 634/655 (96.8%) | 604/639 (94.5%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 78/655 (11.9%) | 42/639 (6.6%) | ||
| Constipation | 34/655 (5.2%) | 60/639 (9.4%) | ||
| Nausea | 40/655 (6.1%) | 42/639 (6.6%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 281/655 (42.9%) | 261/639 (40.8%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 58/655 (8.9%) | 69/639 (10.8%) | ||
| Contusion | 46/655 (7%) | 60/639 (9.4%) | ||
| Post procedural haemorrhage | 46/655 (7%) | 43/639 (6.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 58/655 (8.9%) | 59/639 (9.2%) | ||
| Arthralgia | 34/655 (5.2%) | 39/639 (6.1%) | ||
| Nervous system disorders | ||||
| Headache | 293/655 (44.7%) | 187/639 (29.3%) | ||
| Dizziness | 58/655 (8.9%) | 55/639 (8.6%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Eczema | 30/655 (4.6%) | 42/639 (6.6%) | ||
| Vascular disorders | ||||
| Hypertension | 37/655 (5.6%) | 53/639 (8.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00311402
Other Study ID Numbers:
- 9.178
First Posted:
Apr 6, 2006
Last Update Posted:
Feb 14, 2014
Last Verified:
Jan 1, 2014