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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00311402 |
Purpose
Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Drug: Aggrenox capsule Other: Acetylsalicylic Acid (ASA) |
Phase III |
| Study Type: | Interventional |
| Study Design: | 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 |
| Enrollment: | 1295 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Aggrenox Capsule |
Drug: Aggrenox capsule
extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
|
| Acetylsalicylic Acid (ASA) 81 mg Tablet |
Other: Acetylsalicylic Acid (ASA)
Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| 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 at least two of the following risk factors:
Exclusion Criteria:
Contacts and Locations
Show 151 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00311402 History of Changes |
| Other Study ID Numbers: | 9.178 |
| Study First Received: | March 28, 2006 |
| Results First Received: | February 16, 2010 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Aspirin Aspirin, dipyridamole drug combination Dipyridamole Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors |