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JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebrovascular Accident

Intervention: Aggrenox capsule (Drug); ASA 81 mg tablet (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Nippon Boehringer Ingelheim Co., Ltd.

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

Clinical Details

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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Recurrence of brain infarction (fatal or non-fatal)

Secondary outcome: Brain hemorrhage Subarachnoid hemorrhage Transient ischemic attack (TIA) Acute coronary syndromes (myocardial infarction, angina unstable, cardiac death) Other vascular events

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

INCLUSION CRITERIA:

Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee?s classification of cerebrovascular disease III.

1. Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)

2. Patients who are 50 years or older

3. Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator

4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray CT or MRI

5. Patients who have at least two of the following risk factors:

- diabetes

- hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood

pressure is 90 mmHg or higher) or under treatment of hypertension

- smoker (at the time of onset of cerebral infarction)

- obesity (BMI is more than 25 kg/m2)

- previous vascular disease (stroke, acute myocardial infarction or peripheral

arterial disease before the onset of cerebral infarction)

- end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or

microalbuminuria)

- hyperlipidaemia

EXCLUSION CRITERIA:

1. Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral AV malformation, cerebral AV aneurysms and brain tumours

2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism

3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study

4. Patient with hypersensitivity to dipyridamole preparations

5. Patients with a history of drug allergy to ASA or aspirin asthma

6. Patients with a history of peptic ulcer

7. Patients having undergone arterial reconstruction after development of cerebral infarction

8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale)

9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)

10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)

11. Patients with complications such as serious cardiac, renal and hepatic disorders

12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years

13. Women who are or may be pregnant or lactating women

Locations and Contacts

Boehringer Ingelheim Investigational Site, Higashi-ku, Sappro, Hokkaido 007-0844, Japan

Boehringer Ingelheim Investigational Site, Chuo-Ku, Sappro, Hokkaido 064-0953, Japan

Boehringer Ingelheim Investigational Site, Takikawa, Hokkaido 073-0044, Japan

Boehringer Ingelheim Investigational Site, Kita-ku, Sappro, Hokkaido 001-0906, Japan

Boehringer Ingelheim Investigational Site, Hitachinaka, Ibaraki 312-0057, Japan

Boehringer Ingelheim Investigational Site, Tsuchiura, Ibaraki 300-0053, Japan

Boehringer Ingelheim Investigational Site, Toride, Ibaraki 302-0022, Japan

Boehringer Ingelheim Investigational Site, Kasama, Ibaraki 309-1703, Japan

Boehringer Ingelheim Investigational Site, Moriya, Ibaraki 302-0118, Japan

Boehringer Ingelheim Investigational Site, Isesaki, Gunma 372-0812, Japan

Boehringer Ingelheim Investigational Site, Musashino, Tokyo 180-0003, Japan

Boehringer Ingelheim Investigational Site, Midori-ku, Yokohama, Kanagawa 226-0025, Japan

Boehringer Ingelheim Investigational Site, Suwa, Nagano 392-0027, Japan

Boehringer Ingelheim Investigational Site, Matsumoto, Nagano 390-0814, Japan

Boehringer Ingelheim Investigational Site, Adumino, Nagano 399-8205, Japan

Boehringer Ingelheim Investigational Site, Ueda, Nagano 386-0396, Japan

Boehringer Ingelheim Investigational Site, Saku, Nagano 384-0301, Japan

Boehringer Ingelheim Investigational Site, Iida, Nagano 395-0004, Japan

Boehringer Ingelheim Investigational Site, Naka-ku, Nagoya, Aichi 460-0001, Japan

Boehringer Ingelheim Investigational Site, Kanazawa, Ishikawa 920-0939, Japan

Boehringer Ingelheim Investigational Site, Shimogyo-ku, Kyoto, Kyoto 600-8811, Japan

Boehringer Ingelheim Investigational Site, Kita-ku, Osaka, Osaka 530-8480, Japan

Boehringer Ingelheim Investigational Site, Habikino, Osaka 583-0852, Japan

Boehringer Ingelheim Investigational Site, Higashi-osaka, Osaka 579-8026, Japan

Boehringer Ingelheim Investigational Site, Sakai, Osaka 590-0064, Japan

Boehringer Ingelheim Investigational Site, Suminoe-ku, Osaka, Osaka 559-0003, Japan

Boehringer Ingelheim Investigational Site, Nishi-yodogawa-ku, Osaka, Osaka 555-0001, Japan

Boehringer Ingelheim Investigational Site, Chuo-ku, Kobe, Hyogo 651-0072, Japan

Boehringer Ingelheim Investigational Site, Itami, Hyogo 664-8533, Japan

Boehringer Ingelheim Investigational Site, Ohnojo, Fukuoka 816-0943, Japan

Boehringer Ingelheim Investigational Site, Kasuga, Fukuoka 816-0864, Japan

Boehringer Ingelheim Investigational Site, Sawara-ku, Fukuoka, Fukuoka 814-0171, Japan

Boehringer Ingelheim Investigational Site, Kasuga, Fukuoka 816-0802, Japan

Boehringer Ingelheim Investigational Site, Takasaki, Gunma 370-0852, Japan

Boehringer Ingelheim Investigational Site, Tatebayashi, Gunma 374-0055, Japan

Boehringer Ingelheim Investigational Site, Setagaya-ku, Tokyo 158-0098, Japan

Boehringer Ingelheim Investigational Site, Minami-ku, Hiroshima, Hiroshima 734-8530, Japan

Boehringer Ingelheim Investigational Site, Jyonan-ku, Fukuoka, Fukuoka 814-0153, Japan

Boehringer Ingelheim Investigational Site, Isesaki, Gunma 372-0006, Japan

Boehringer Ingelheim Investigational Site, Fukaya, Saitama 366-0052, Japan

Boehringer Ingelheim Investigational Site, Toyama, Toyama 930-0152, Japan

Boehringer Ingelheim Investigational Site, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan

Boehringer Ingelheim Investigational Site, Kawachinagano, Osaka 586-0008, Japan

Boehringer Ingelheim Investigational Site, Hamada, Shimane 697-8511, Japan

Boehringer Ingelheim Investigational Site, Akashi, Hyogo 674-0081, Japan

Boehringer Ingelheim Investigational Site, Nakagawa-ku, Nagoya, Aichi 454-0933, Japan

Boehringer Ingelheim Investigational Site, Chitose, Hokkaido 066-0034, Japan

Boehringer Ingelheim Investigational Site, Shiroishi, Miyagi 989-0231, Japan

Boehringer Ingelheim Investigational Site, Asahi, Chiba 289-2511, Japan

Boehringer Ingelheim Investigational Site, Meito-ku, Nagoya, Aichi 465-8620, Japan

Boehringer Ingelheim Investigational Site, Obu, Aichi 474-8511, Japan

Boehringer Ingelheim Investigational Site, Adachi-ku, Tokyo 121-0076, Japan

Boehringer Ingelheim Investigational Site, Koriyama, Fukushima 963-8052, Japan

Boehringer Ingelheim Investigational Site, Ako, Hyogo 678-0239, Japan

Boehringer Ingelheim Investigational Site, Kushiro, Hokkaido 085-0052, Japan

Boehringer Ingelheim Investigational Site, Aoba-ku, Yokohama, Kanagawa 225-0013, Japan

Boehringer Ingelheim Investigational Site, Teine-ku, Sapporo, Hokkaido 006-8555, Japan

Boehringer Ingelheim Investigational Site, Asahikawa, Hokkaido 078-8801, Japan

Boehringer Ingelheim Investigational Site, Miyagino-ku, Sendai, Miyagi 983-8520, Japan

Boehringer Ingelheim Investigational Site, Kiyose, Tokyo 204-8585, Japan

Boehringer Ingelheim Investigational Site, Musashimurayama, Tokyo 208-0011, Japan

Boehringer Ingelheim Investigational Site, Fushimi-ku, Kyoto, Kyoto 601-1434, Japan

Boehringer Ingelheim Investigational Site, Sakai, Osaka 590-0132, Japan

Boehringer Ingelheim Investigational Site, Akashi, Hyogo 674-0064, Japan

Boehringer Ingelheim Investigational Site, Koshi, Kumamoto 861-1196, Japan

Boehringer Ingelheim Investigational Site, Shimotsuke, Tochigi 329-0431, Japan

Boehringer Ingelheim Investigational Site, Chuo-ku, Sapporo, Hokkaido 060-0022, Japan

Boehringer Ingelheim Investigational Site, Morioka, Iwate 020-0023, Japan

Boehringer Ingelheim Investigational Site, Ibusuki, Kagoshima 891-0498, Japan

Boehringer Ingelheim Investigational Site, Gifu, Gifu 500-8523, Japan

Boehringer Ingelheim Investigational Site, Izumisano, Osaka, Japan

Boehringer Ingelheim Investigational Site, Hakodate, Hokkaido 041-0802, Japan

Boehringer Ingelheim Investigational Site, Kushiro, Hokkaido 085-0061, Japan

Boehringer Ingelheim Investigational Site, Morioka, Iwate 020-0103, Japan

Boehringer Ingelheim Investigational Site, Koriyama, Fukushima 963-8558, Japan

Boehringer Ingelheim Investigational Site, Kisarazu, Chiba 292-8535, Japan

Boehringer Ingelheim Investigational Site, Noda, Chiba 278-8501, Japan

Boehringer Ingelheim Investigational Site, Shibuya-ku, Tokyo 151-0053, Japan

Boehringer Ingelheim Investigational Site, Bunkyo-ku, Tokyo 113-8431, Japan

Boehringer Ingelheim Investigational Site, Toyohashi, Aichi 440-8510, Japan

Boehringer Ingelheim Investigational Site, Uji, Kyoto 611-0011, Japan

Boehringer Ingelheim Investigational Site, Kamigyo-ku, Kyoto, Kyoto 602-8026, Japan

Boehringer Ingelheim Investigational Site, Himeji, Hyogo 670-0981, Japan

Boehringer Ingelheim Investigational Site, Izuka, Fukuoka 820-8505, Japan

Boehringer Ingelheim Investigational Site, Nishisonogi-gun, Nagasaki 851-2103, Japan

Boehringer Ingelheim Investigational Site, Aoi-ku, Shizuoka, Shizuoka 420-8527, Japan

Boehringer Ingelheim Investigational Site, Fujieda, Shizuoka 426-8677, Japan

Boehringer Ingelheim Investigational Site, Fukuroi, Shizuoka 437-0061, Japan

Boehringer Ingelheim Investigational Site, Naka-ku, Hamamatsu, Shizuoka 432-8580, Japan

Boehringer Ingelheim Investigational Site, Higashiyodogawa-ku, Osaka, Osaka 533-0022, Japan

Boehringer Ingelheim Investigational Site, Kita-ku, Nagoya, Aichi 462-0802, Japan

Boehringer Ingelheim Investigational Site, Yao, Osaka 581-0036, Japan

Boehringer Ingelheim Investigational Site, Iwata, Shizuoka 438-8550, Japan

Boehringer Ingelheim Investigational Site, Hamamatsu, Shizuoka 430-0907, Japan

Boehringer Ingelheim Investigational Site, Urayasu, Chiba 279-0021, Japan

Boehringer Ingelheim Investigational Site, Kurashiki, Okayama 712-8064, Japan

Boehringer Ingelheim Investigational Site, Yanai, Yamaguchi 742-0032, Japan

Boehringer Ingelheim Investigational Site, Naka-ku, Hamamatsu, Shizuoka 430-0929, Japan

Boehringer Ingelheim Investigational Site, Simizu-ku, Shizuoka, Shizuoka 424-8636, Japan

Boehringer Ingelheim Investigational Site, Fuchu, Tokyo 183-0046, Japan

Boehringer Ingelheim Investigational Site, Izunokuni, Shizuoka 410-2295, Japan

Boehringer Ingelheim Investigational Site, Wko, Saitama 351-0102, Japan

Boehringer Ingelheim Investigational Site, Kahoku-gun, Ishikawa 920-0293, Japan

Boehringer Ingelheim Investigational Site, Miyazaki, Miyazaki 880-2112, Japan

Boehringer Ingelheim Investigational Site, Asahikawa, Hokkaido 070-8530, Japan

Boehringer Ingelheim Investigational Site, Hakodate, Hokkaido 041-8609, Japan

Boehringer Ingelheim Investigational Site, Chuo-ku, Sappro, Hokkaido 060-0061, Japan

Boehringer Ingelheim Investigational Site, Higashimatsushima, Miyagi 981-0501, Japan

Boehringer Ingelheim Investigational Site, Kochi, Kochi 780-8522, Japan

Boehringer Ingelheim Investigational Site, Chofu, Tokyo 182-0034, Japan

Boehringer Ingelheim Investigational Site, Higashisonogi-gun, Nagasaki 859-3615, Japan

Boehringer Ingelheim Investigational Site, Namegata, Ibaraki 311-3516, Japan

Boehringer Ingelheim Investigational Site, Yamashina, Kyoto, Kyoto 607-8062, Japan

Boehringer Ingelheim Investigational Site, Kushiro, Hokkaido 084-0912, Japan

Boehringer Ingelheim Investigational Site, Kita-ku, Osaka, Osaka 530-0012, Japan

Boehringer Ingelheim Investigational Site, Eniwa, Hokkaido 061-1395, Japan

Boehringer Ingelheim Investigational Site, Inashiki-gun, Ibaraki 300-0331, Japan

Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo 153-8934, Japan

Boehringer Ingelheim Investigational Site, Toyota, Aichi 471-8513, Japan

Boehringer Ingelheim Investigational Site, Nakagawa-ku, Nagoya, Nagoya 454-8502, Japan

Boehringer Ingelheim Investigational Site, Chuo-ku, Chiba, Chiba 260-8606, Japan

Boehringer Ingelheim Investigational Site, Tenri, Nara 632-8552, Japan

Boehringer Ingelheim Investigational Site, Iwanuma, Miyagi 989-2483, Japan

Boehringer Ingelheim Investigational Site, Hachioji, Tokyo 192-0045, Japan

Boehringer Ingelheim Investigational Site, Sagamihara, Kanagawa 228-8522, Japan

Boehringer Ingelheim Investigational Site, Hashima-gun, Gifu 501-6062, Japan

Boehringer Ingelheim Investigational Site, Izumo, Shimane 693-8501, Japan

Boehringer Ingelheim Investigational Site, Higashiosaka, Osaka 578-8588, Japan

Boehringer Ingelheim Investigational Site, Kochi, Kochi 781-0011, Japan

Boehringer Ingelheim Investigational Site, Moriguchi, Osaka 570-8540, Japan

Boehringer Ingelheim Investigational Site, Ichikawa, Chiba 272-0001, Japan

Boehringer Ingelheim Investigational Site, Takayama, Gifu 506-8550, Japan

Boehringer Ingelheim Investigational Site, Fukui, Fukui 910-8561, Japan

Boehringer Ingelheim Investigational Site, Takatsuki, Osaka 569-1096, Japan

Boehringer Ingelheim Investigational Site, Kameda-gun, Hokkaido 041-1111, Japan

Boehringer Ingelheim Investigational Site, Wakayama, Wakayama 640-8158, Japan

Boehringer Ingelheim Investigational Site, Moriya, Ibaraki 302-0112, Japan

Boehringer Ingelheim Investigational Site, Marugame, Kagawa 763-8502, Japan

Boehringer Ingelheim Investigational Site, Suminoe-ku, Osaka, Osaka 559-0006, Japan

Boehringer Ingelheim Investigational Site, Yaizu, Shizuoka 425-8505, Japan

Boehringer Ingelheim Investigational Site, Hitachi, Ibaraki 317-0077, Japan

Boehringer Ingelheim Investigational Site, Kitami, Hokkaido 090-0836, Japan

Boehringer Ingelheim Investigational Site, Kitami, Hokkaido 090-0062, Japan

Boehringer Ingelheim Investigational Site, Susono, Shizuoka 410-1128, Japan

Boehringer Ingelheim Investigational Site, Okayama, Okayama 702-8055, Japan

Boehringer Ingelheim Investigational Site, Nanao, Ishikawa 926-8605, Japan

Boehringer Ingelheim Investigational Site, Tonami, Toyama 939-1395, Japan

Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido 065-0033, Japan

Boehringer Ingelheim Investigational Site, Daito, Osaka 574-0074, Japan

Boehringer Ingelheim Investigational Site, Kishiwada, Osaka 596-8522, Japan

Boehringer Ingelheim Investigational Site, Higashidakawa-gun, Yamagata 999-7782, Japan

Boehringer Ingelheim Investigational Site, Matsudo, Chiba 270-2251, Japan

Boehringer Ingelheim Investigational Site, Funabashi, Chiba 274-8503, Japan

Boehringer Ingelheim Investigational Site, Atsugi, Kanagawa 243-8551, Japan

Boehringer Ingelheim Investigational Site, Okinawa, Okinawa 904-8585, Japan

Boehringer Ingelheim Investigational Site, Iruma-gun, Saitama 350-0495, Japan

Boehringer Ingelheim Investigational Site, Hidaka, Saitama 350-1298, Japan

Additional Information


Ending date: July 2009
Last updated: April 25, 2008

Page last updated: June 20, 2008

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