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”

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 Type: Interventional

Study Design: Double-Blind

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Aggrenox capsule
  • 1 capsule Twice a day
• Drug: ASA 81 mg tablet
  • 1 tablet Once a day

Primary Measures

• Recurrence of brain infarction (fatal or non-fatal)
  • Time Frame: 52 weeks to 124 weeks
    

Secondary Measures

• Brain hemorrhage Subarachnoid hemorrhage Transient ischemic attack (TIA) Acute coronary syndromes (myocardial infarction, angina unstable, cardiac death) Other vascular events
  • Time Frame: 52 weeks to 124 weeks
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00311402

Study ID Number: 9.178

ClinicalTrials.gov Identifier: NCT00311402

Health Authority: Japan: Ministry of Health, Labor and Welfare